On this page
Metformin Hydrochloride
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Biguanide [EPC] | EPC | All 47 members |
| Biguanides [CS] | CS | All 47 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 077095-001 | METFORMIN HYDROCHLORIDE | TABLET | METFORMIN HYDROCHLORIDE | Prescription | AB | ||
| 077095-002 | METFORMIN HYDROCHLORIDE | TABLET | METFORMIN HYDROCHLORIDE | Prescription | AB | ||
| 077095-003 | METFORMIN HYDROCHLORIDE | TABLET | METFORMIN HYDROCHLORIDE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 35 | Labeling | Approved | August 11, 2026 | Standard |
| Supplement | 32 | Manufacturing (CMC) | Approved | March 29, 2024 | Unknown |
| Supplement | 24 | Labeling | Approved | February 14, 2019 | Standard |
| Supplement | 23 | Labeling | Approved | February 14, 2019 | Standard |
| Supplement | 8 | Labeling | Approved | May 12, 2009 | — |
| Supplement | 6 | Labeling | Approved | May 12, 2009 | — |
| Supplement | 9 | Labeling | Approved | October 29, 2008 | — |
| Supplement | 2 | Labeling | Approved | March 16, 2007 | — |
| Original application | 1 | Approved | January 14, 2005 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260812). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingLactic Acidosis Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patie …
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Boxed Warning 04/2026 Warnings And Precautions, Lactic Acidosis (5.1) 06/2026
Indications and Usage
openFDA Drug Labeling1 INDICATIONS & USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 ) Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride tablets is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age). Metformin hydrochloride tablets should be given in divided doses with meals and should be started at a low dose, with gradual dose escalation, to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule ), fasting plasma glucose should be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness. Short-term administration of metformin may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Recommended Dosing Schedule Adults The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day or 850 mg once a day, given with meals. In general, clinically significant responses are not seen at doses below 1500 mg per day. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. The dosage of metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerability. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, metformin hydrochloride tablets may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given 3 times a day with meals. Pediatrics The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses. The dosage of metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerability. Recommendations for Use in Renal Impairment Assess renal function prior to initiation of metformin hydrochloride tablets and periodically thereafter. Metformin hydrochloride tablet is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of metformin hydrochloride tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. In patients taking metformin hydrochloride tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. Discontinue metformin hydrochloride tablets if the patient's eGFR later falls below 30 mL/minute/1.73 m 2 (See WARNINGS and PRECAUTIONS ). Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism or h …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS & STRENGTHS Metformin hydrochloride tablets,USP: • Metformin hydrochloride tablets, USP 500 mg are white to off white,circular, biconvex, film coated, beveled edge tablets, debossed with "C74" on one side and plain on other side. • Metformin hydrochloride tablets, USP 850 mg are white to off white,circular, biconvex, film coated, beveled edge tablets, debossed with "C75" on one side and plain on other side. • Metformin hydrochloride tablets, USP 1000 mg are white to off white, oval shaped, biconvex, film coated tablet, debossed with "C" and "76" separated by breakline on both sides (functional scoring). Metformin hydrochloride extended-release tablets,USP: • Metformin hydrochloride extended-release tablets, USP 500 mg are white to off white, capsule shaped, biconvex, film coated tablets debossed with "ML30" on one side and plain on the other side. • Metformin hydrochloride extended-release tablets, USP 750 mg are pink capsule shaped, biconvex, film coated tablets debossed with "ML31" on one side and plain on the other side. • Metformin hydrochloride tablets: 500 mg, 850 mg, and 1000 mg ( 3 ) • Metformin hydrochloride extended-release tablets: 500 mg and 750 mg ( 3 )
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Metformin hydrochloride tablets are contraindicated in patients with: 1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). 2. Known hypersensitivity to metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS .)
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Lactic Acidosis: See boxed warning. ( 5.1 ) Vitamin B12 Deficiency: Metformin may lower vitamin B12 levels. Measure hematological parameters annually and vitamin B12 at 2 to 3 year intervals and manage any abnormalities. ( 5.2 ) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required ( 5.3 ) 5.1 Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels were generally >5 mcg/mL. Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of metformin hydrochloride tablets and metformin hydrochloride extended-release tablets. In metformin hydrochloride tablets and metformin hydrochloride extended-release tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery. Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue metformin hydrochloride tablets and metformin hydrochloride extended-release tablets and report these symptoms to their healthcare provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: Renal impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 ) ]: o Before initiating metformin hydrochloride tablets and metformin hydrochloride extended-release tablets, obtain an estimated glomerular filtration rate (eGFR). o Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [see C ontraindications (4) ]. o Initiation of metformin hydrochloride tablets and metformin hydrochloride extended-release tablets is not recommended in patients with eGFR between 30-45 mL/min/1.73 m 2 . o Obtain an eGFR at least annually in all patients taking metformin hydrochloride tablets/ metformin hydrochloride extended-release tablets. In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently. o In patients taking metformin hydrochloride tablets and metformin hydrochloride extended-release tablets whose eGFR falls below 45 mL/min/1.73 m 2 , assess the benefit and risk of continuing therapy. Drug interactions — The concomitant use of metformin hydrochl …
Warnings
openFDA Drug LabelingWARNINGS Lactic Acidosis Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Lactic Acidosis [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] • Vitamin B 12 Deficiency [ see Warnings and Precautions ( 5.2 ) ] • Hypoglycemia [see Warnings and Precautions ( 5.3 ) ] For metformin hydrochloride tablets/metformin hydrochloride extended-release tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metformin hydrochloride tablets In a U.S. clinical trial of metformin hydrochloride tablets in patients with type 2 diabetes mellitus, a total of 141 patients received metformin hydrochloride tablets up to 2550 mg per day. Adverse reactions reported in greater than 5% of metformin hydrochloride tablets treated patients and that were more common than in placebo-treated patients, are listed in Table 1. Table 1: Adverse Reactions from a Clinical Trial of Metformin Hydrochloride Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin hydrochloride tablets (n=141) Placebo (n=145) Diarrhea 53% 12% Nausea/Vomiting 26% 8% Flatulence 12% 6% Asthenia 9% 6% Indigestion 7% 4% Abdominal Discomfort 6% 5% Headache 6% 5% Diarrhea led to discontinuation of metformin hydrochloride tablets in 6% of patients. Additionally, the following adverse reactions were reported in ≥1% to ≤5% of metformin hydrochloride tablets treated patients and were more commonly reported with metformin hydrochloride tablets than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation. In metformin hydrochloride tablets clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients. Pediatric Patients In clinical trials with metformin hydrochloride tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in adults. Metformin hydrochloride extended-release tablets In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release tablets patients, and that were more common in metformin hydrochloride extended-release tablets -than placebo-treated patients, are listed in Table 2. Table 2: Adverse Reactions from Clinical Trials of Metformin Hydrochloride Extended-Release Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin hydrochloride extended-release Tablets (n=781) Placebo (n=195) Diarrhea 10% 3% Nausea/Vomiting 7% 2% Diarrhea led to discontinuation of metformin hydrochloride extended-release tablets in 0.6% of patients. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of metformin hydrochloride extended-release tablets patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a p …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Table 3 presents clinically significant drug interactions with metformin hydrochloride tablets. Table 3: Clinically Significant Drug Interactions with Metformin Hydrochloride Tablets Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with metformin hydrochloride tablets may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce Metformin Hydrochloride Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see Clinical Pharmacology (12.3) ] . Intervention: Consider the benefits and risks of concomitant use with metformin hydrochloride tablets. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of metformin on lactate metabolism. Intervention: Warn patients against excessive alcohol intake while receiving metformin hydrochloride tablets. Insulin Secretagogues or Insulin Clinical Impact: Coadministration of metformin hydrochloride tablets with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia. Intervention: Patients receiving an insulin secretagogue or insulin may require lower doses of the insulin secretagogue or insulin. Drugs Affecting Glycemic Control Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. Intervention: When such drugs are administered to a patient receiving metformin hydrochloride tablets, observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving metformin hydrochloride tablets, observe the patient closely for hypoglycemia. Examples: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. • Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring ( 7 ) • Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use ( 7 ) • Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake ( 7 )
Drug Interactions In Vivo Assessment of Drug Interactions Table 5: Effect of Coadministered Drug on Plasma Metformin Systemic Exposure Coadministered Drug Dose of Coadministered Drug All metformin and coadministered drugs were given as single doses Dose of Metformin Geometric Mean Ratio (ratio with/without coadministered drug) No Effect = 1.00 AUC AUC = AUC(INF) C max No dosing adjustments required for the following: Glyburide 5 mg 850 mg metformin 0.91 Ratio of arithmetic means 0.93 Furosemide 40 mg 850 mg metformin 1.09 1.22 Nifedipine 10 mg 850 mg metformin 1.16 1.21 Propranolol 40 mg 850 mg metformin 0.90 0.94 Ibuprofen 400 mg 850 mg metformin 1.05 1.07 Cationic drugs eliminated by renal tubular secretion may reduce metformin elimination [ See Drug Interactions (7) . ] Cimetidine 400 mg 850 mg metformin 1.40 1.61 Carbonic anhydrase inhibitors may cause metabolic acidosis [ See Warnings and Precautions (5.1) and Drug Interactions (7) . ] Topiramate 100 mg At steady state with topiramate 100 mg every 12 hours and metformin 500 mg every 12 hours; AUC = AUC0-12h 500 mg metformin 1.25 1.17 Table 6: Effect of Metformin o …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. ( 8.3 ) Geriatric Use: Assess renal function more frequently. ( 8.5 ) Hepatic Impairment: Avoid use in patients with hepatic impairment. ( 8.7 ) 8.1 Pregnancy Risk Summary Limited data with metformin hydrochloride tablets and metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations]. No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see Data]. The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20–25% in women with a HbA1C >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin. 8.2 Lactation Risk Summary Limited published studies report that metformin is present in human milk [see Data]. However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metformin hydrochloride tablets and metformin hydrochloride extended-release tablets and any potential adverse effects on the breastfed child from metformin hydrochloride tablets and metformin hydrochloride extended-release tablets or from the underlying maternal condition. Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. 8.3 Females and Males of Reproductive Potential Discuss the potential for …
Mechanism of Action
openFDA Drug LabelingMechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
Description
openFDA Drug Labeling11 DESCRIPTION Metformin hydrochloride tablets, USP/ metformin hydrochloride extended-release tablets,USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N -dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets,USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, microcrystalline cellulose, sodium starch glycolate and magnesium stearate. In addition, the coating for the tablets contains hypromellose and polyethylene glycol. Metformin hydrochloride extended-release tablets,USP contain 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. Each tablet contains the inactive ingredients carbomer homopolymer type A, magnesium trisilicate, dibasic calcium phosphate anhydrous, hydroxyl propyl cellulose, xanthan gum, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. Metformin hydrochloride extended-release tablets 750 mg also contain iron oxide red. Metformin hydrochloride extended-release tablets: USP Dissolution test is pending. metformin hydrochloride structure
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions ( 5.1 ) ]. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Metformin Hydrochloride Tablets USP, 500 mg are white to off-white, round shaped, film-coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows. NDC 68382-758-16 in bottles of 90 tablets NDC 68382-758-01 in bottles of 100 tablets NDC 68382-758-05 in bottles of 500 tablets NDC 68382-758-10 in bottles of 1,000 tablets NDC 68382-758-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Metformin Hydrochloride Tablets USP, 850 mg are white to off-white, oval shaped, film-coated tablets debossed with the logo of "69" on one side and "Z" on the other side and are supplied as follows. NDC 68382-759-16 in bottles of 90 tablets NDC 68382-759-01 in bottles of 100 tablets NDC 68382-759-05 in bottles of 500 tablets NDC 68382-759-10 in bottles of 1,000 tablets NDC 68382-759-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Metformin Hydrochloride Tablets USP, 1,000 mg are white to off-white, oval shaped, biconvex, film-coated tablets with bisect on both the sides; one side of the bisect is debossed with "Z" and other side of the bisect is debossed with "71" and are supplied as follows. NDC 68382-760-16 in bottles of 90 tablets NDC 68382-760-01 in bottles of 100 tablets NDC 68382-760-05 in bottles of 500 tablets NDC 68382-760-10 in bottles of 1,000 tablets NDC 68382-760-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets 16.2 Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers.
16.1 How Supplied Metformin Hydrochloride Tablets USP, 500 mg are white to off-white, round shaped, film-coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows. NDC 68382-758-16 in bottles of 90 tablets NDC 68382-758-01 in bottles of 100 tablets NDC 68382-758-05 in bottles of 500 tablets NDC 68382-758-10 in bottles of 1,000 tablets NDC 68382-758-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Metformin Hydrochloride Tablets USP, 850 mg are white to off-white, oval shaped, film-coated tablets debossed with the logo of "69" on one side and "Z" on the other side and are supplied as follows. NDC 68382-759-16 in bottles of 90 tablets NDC 68382-759-01 in bottles of 100 tablets NDC 68382-759-05 in bottles of 500 tablets NDC 68382-759-10 in bottles of 1,000 tablets NDC 68382-759-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Metformin Hydrochloride Tablets USP, 1,000 mg are white to off-white, oval shaped, biconvex, film-coated tablets with bisect on both the sides; one side of the bisect is debossed with "Z" and other side of the bisect is debossed with "71" and are supplied as follows. NDC 68382-760-16 in bottles of 90 tablets NDC 68382-760-01 in bottles of 100 tablets NDC 68382-760-05 in bottles of 500 tablets NDC 68382-760-10 in bottles of 1,000 tablets NDC 68382-760-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: METFORMIN HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class III | February 28, 2018 | Aurobindo Pharma Ltd. | Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg | Terminated |
| Class II | December 7, 2016 | Ascend Laboratories LLC | Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2081-0 | 50090-2081 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-2081-0) | October 8, 2015 |
| 50090-2081-3 | 50090-2081 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-2081-3) | October 8, 2015 |
| 50090-2081-4 | 50090-2081 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2081-4) | October 8, 2015 |
| 50090-2081-5 | 50090-2081 | A-S Medication Solutions | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-2081-5) | October 8, 2015 |
| 50090-2081-6 | 50090-2081 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-2081-6) | October 8, 2015 |
| 50090-5052-0 | 50090-5052 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5052-0) | May 19, 2020 |
| 50090-6485-0 | 50090-6485 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6485-0) | May 17, 2023 |
| 50090-6856-0 | 50090-6856 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6856-0) | December 1, 2023 |
| 50090-6856-2 | 50090-6856 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6856-2) | December 1, 2023 |
| 50090-6856-3 | 50090-6856 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6856-3) | December 1, 2023 |
| 50090-6856-4 | 50090-6856 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6856-4) | December 1, 2023 |
| 50090-6856-5 | 50090-6856 | A-S Medication Solutions | 180 TABLET, FILM COATED in 1 BOTTLE (50090-6856-5) | December 1, 2023 |
| 50090-6857-0 | 50090-6857 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6857-0) | December 1, 2023 |
| 50090-6858-0 | 50090-6858 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6858-0) | December 1, 2023 |
| 50090-6858-3 | 50090-6858 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6858-3) | December 1, 2023 |
| 50090-6858-4 | 50090-6858 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6858-4) | December 1, 2023 |
| 50090-6858-5 | 50090-6858 | A-S Medication Solutions | 180 TABLET, FILM COATED in 1 BOTTLE (50090-6858-5) | December 1, 2023 |
| 50090-6858-6 | 50090-6858 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6858-6) | December 1, 2023 |
| 50090-6859-0 | 50090-6859 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6859-0) | December 1, 2023 |
| 50090-7106-0 | 50090-7106 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7106-0) | March 6, 2024 |
| 50090-7106-2 | 50090-7106 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7106-2) | March 6, 2024 |
| 50090-7106-4 | 50090-7106 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7106-4) | March 6, 2024 |
| 50090-7106-5 | 50090-7106 | A-S Medication Solutions | 180 TABLET, FILM COATED in 1 BOTTLE (50090-7106-5) | March 6, 2024 |
| 50090-7107-0 | 50090-7107 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7107-0) | March 6, 2024 |
| 50090-7866-0 | 50090-7866 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7866-0) | January 26, 2026 |
| 50090-7868-0 | 50090-7868 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7868-0) | January 29, 2026 |
| 50090-7877-0 | 50090-7877 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7877-0) | February 2, 2026 |
| 50090-7877-2 | 50090-7877 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7877-2) | February 2, 2026 |
| 50090-7877-3 | 50090-7877 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7877-3) | February 2, 2026 |
| 50090-7877-4 | 50090-7877 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7877-4) | February 2, 2026 |
| 50090-7877-5 | 50090-7877 | A-S Medication Solutions | 180 TABLET, FILM COATED in 1 BOTTLE (50090-7877-5) | February 2, 2026 |
| 50090-7878-0 | 50090-7878 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7878-0) | February 2, 2026 |
| 50090-8041-0 | 50090-8041 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-8041-0) | August 27, 2026 |
| 50090-8041-3 | 50090-8041 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-8041-3) | August 27, 2026 |
| 50090-8041-4 | 50090-8041 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-8041-4) | August 27, 2026 |
| 50090-8041-5 | 50090-8041 | A-S Medication Solutions | 180 TABLET, FILM COATED in 1 BOTTLE (50090-8041-5) | August 27, 2026 |
| 50090-8041-6 | 50090-8041 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-8041-6) | August 27, 2026 |
| 50090-8043-0 | 50090-8043 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-8043-0) | August 27, 2026 |
| 80425-0591-1 | 80425-0591 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-1) | July 10, 2026 |
| 80425-0591-2 | 80425-0591 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-2) | July 10, 2026 |
| 80425-0591-3 | 80425-0591 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-3) | July 10, 2026 |
| 80425-0591-4 | 80425-0591 | Advanced Rx of Tennessee, LLC | 108 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-4) | July 10, 2026 |
| 60687-143-01 | 60687-143 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-143-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-143-11) | September 9, 2015 |
| 60687-155-01 | 60687-155 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-155-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-155-11) | April 4, 2016 |
| 60687-162-01 | 60687-162 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-162-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-162-11) | October 15, 2015 |
| 71610-920-53 | 71610-920 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-920-53) | July 1, 2025 |
| 71610-920-60 | 71610-920 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-920-60) | July 1, 2025 |
| 71610-920-80 | 71610-920 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-920-80) | July 1, 2025 |
| 71610-929-30 | 71610-929 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-929-30) | July 22, 2025 |
| 71610-929-53 | 71610-929 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-929-53) | July 22, 2025 |
| 71610-929-60 | 71610-929 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-929-60) | July 22, 2025 |
| 71610-929-70 | 71610-929 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (71610-929-70) | July 22, 2025 |
| 71610-929-80 | 71610-929 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-929-80) | July 22, 2025 |
| 71610-929-94 | 71610-929 | Aphena Pharma Solutions - Tennessee, LLC | 360 TABLET, FILM COATED in 1 BOTTLE (71610-929-94) | July 22, 2025 |
| 71610-941-60 | 71610-941 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-941-60) | August 25, 2025 |
| 71610-941-80 | 71610-941 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-941-80) | August 25, 2025 |
| 67877-217-01 | 67877-217 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-217-01) | January 31, 2011 |
| 67877-217-05 | 67877-217 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-217-05) | January 31, 2011 |
| 67877-217-10 | 67877-217 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-217-10) | January 31, 2011 |
| 67877-217-38 | 67877-217 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-217-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-217-33) | January 31, 2011 |
| 67877-218-01 | 67877-218 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-218-01) | January 31, 2011 |
| 67877-218-05 | 67877-218 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-218-05) | January 31, 2011 |
| 67877-218-10 | 67877-218 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-218-10) | January 31, 2011 |
| 67877-218-38 | 67877-218 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-218-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-218-33) | January 31, 2011 |
| 67877-221-01 | 67877-221 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-221-01) | January 31, 2011 |
| 67877-221-05 | 67877-221 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-221-05) | January 31, 2011 |
| 67877-221-10 | 67877-221 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-221-10) | January 31, 2011 |
| 67877-221-38 | 67877-221 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-221-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33) | January 31, 2011 |
| 67877-930-01 | 67877-930 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-930-01) | August 25, 2025 |
| 67877-930-05 | 67877-930 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-930-05) | August 25, 2025 |
| 67877-930-10 | 67877-930 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-930-10) | August 25, 2025 |
| 67877-931-01 | 67877-931 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-931-01) | August 25, 2025 |
| 67877-931-05 | 67877-931 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-931-05) | August 25, 2025 |
| 67877-931-10 | 67877-931 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-931-10) | August 25, 2025 |
| 67877-932-01 | 67877-932 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-932-01) | August 25, 2025 |
| 67877-932-05 | 67877-932 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-932-05) | August 25, 2025 |
| 67877-932-10 | 67877-932 | Ascend Laboratories, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-932-10) | August 25, 2025 |
| 59651-854-01 | 59651-854 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-854-01) | March 29, 2024 |
| 59651-854-05 | 59651-854 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-854-05) | March 29, 2024 |
| 59651-854-31 | 59651-854 | Aurobindo Pharma Limited | 2500 TABLET, FILM COATED in 1 BAG (59651-854-31) | March 29, 2024 |
| 59651-854-45 | 59651-854 | Aurobindo Pharma Limited | 4500 TABLET, FILM COATED in 1 BOTTLE (59651-854-45) | March 29, 2024 |
| 59651-854-50 | 59651-854 | Aurobindo Pharma Limited | 50 TABLET, FILM COATED in 1 BOTTLE (59651-854-50) | March 29, 2024 |
| 59651-854-60 | 59651-854 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (59651-854-60) | March 29, 2024 |
| 59651-854-79 | 59651-854 | Aurobindo Pharma Limited | 300 TABLET, FILM COATED in 1 BOTTLE (59651-854-79) | March 29, 2024 |
| 59651-854-90 | 59651-854 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-854-90) | March 29, 2024 |
| 59651-854-99 | 59651-854 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-854-99) | March 29, 2024 |
| 59651-855-01 | 59651-855 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-855-01) | March 29, 2024 |
| 59651-855-05 | 59651-855 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-855-05) | March 29, 2024 |
| 59651-855-26 | 59651-855 | Aurobindo Pharma Limited | 2500 TABLET, FILM COATED in 1 BOTTLE (59651-855-26) | March 29, 2024 |
| 59651-855-29 | 59651-855 | Aurobindo Pharma Limited | 1500 TABLET, FILM COATED in 1 BAG (59651-855-29) | March 29, 2024 |
| 59651-855-50 | 59651-855 | Aurobindo Pharma Limited | 50 TABLET, FILM COATED in 1 BOTTLE (59651-855-50) | March 29, 2024 |
| 59651-855-60 | 59651-855 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (59651-855-60) | March 29, 2024 |
| 59651-855-79 | 59651-855 | Aurobindo Pharma Limited | 300 TABLET, FILM COATED in 1 BOTTLE (59651-855-79) | March 29, 2024 |
| 59651-855-90 | 59651-855 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-855-90) | March 29, 2024 |
| 59651-855-99 | 59651-855 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-855-99) | March 29, 2024 |
| 59651-856-01 | 59651-856 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-856-01) | March 29, 2024 |
| 59651-856-05 | 59651-856 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (59651-856-05) | March 29, 2024 |
| 59651-856-22 | 59651-856 | Aurobindo Pharma Limited | 2000 TABLET, FILM COATED in 1 BOTTLE (59651-856-22) | March 29, 2024 |
| 59651-856-23 | 59651-856 | Aurobindo Pharma Limited | 2000 TABLET, FILM COATED in 1 BAG (59651-856-23) | March 29, 2024 |
| 59651-856-29 | 59651-856 | Aurobindo Pharma Limited | 1500 TABLET, FILM COATED in 1 BAG (59651-856-29) | March 29, 2024 |
| 59651-856-50 | 59651-856 | Aurobindo Pharma Limited | 50 TABLET, FILM COATED in 1 BOTTLE (59651-856-50) | March 29, 2024 |
| 59651-856-60 | 59651-856 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (59651-856-60) | March 29, 2024 |
| 59651-856-79 | 59651-856 | Aurobindo Pharma Limited | 300 TABLET, FILM COATED in 1 BOTTLE (59651-856-79) | March 29, 2024 |
| 59651-856-90 | 59651-856 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (59651-856-90) | March 29, 2024 |
| 59651-856-99 | 59651-856 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-856-99) | March 29, 2024 |
| 65862-008-01 | 65862-008 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65862-008-01) | January 14, 2005 |
| 65862-008-05 | 65862-008 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65862-008-05) | January 14, 2005 |
| 65862-008-26 | 65862-008 | Aurobindo Pharma Limited | 2500 TABLET, FILM COATED in 1 BAG (65862-008-26) | January 14, 2005 |
| 65862-008-33 | 65862-008 | Aurobindo Pharma Limited | 300 TABLET, FILM COATED in 1 BOTTLE (65862-008-33) | January 14, 2005 |
| 65862-008-45 | 65862-008 | Aurobindo Pharma Limited | 4500 TABLET, FILM COATED in 1 BOTTLE (65862-008-45) | January 14, 2005 |
| 65862-008-49 | 65862-008 | Aurobindo Pharma Limited | 4000 TABLET, FILM COATED in 1 BAG (65862-008-49) | January 14, 2005 |
| 65862-008-50 | 65862-008 | Aurobindo Pharma Limited | 50 TABLET, FILM COATED in 1 BOTTLE (65862-008-50) | January 14, 2005 |
| 65862-008-56 | 65862-008 | Aurobindo Pharma Limited | 56000 TABLET, FILM COATED in 1 BAG (65862-008-56) | January 14, 2005 |
| 65862-008-60 | 65862-008 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (65862-008-60) | January 14, 2005 |
| 65862-008-90 | 65862-008 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (65862-008-90) | January 14, 2005 |
| 65862-008-99 | 65862-008 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99) | January 14, 2005 |
| 65862-009-01 | 65862-009 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65862-009-01) | January 14, 2005 |
| 65862-009-05 | 65862-009 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65862-009-05) | January 14, 2005 |
| 65862-009-15 | 65862-009 | Aurobindo Pharma Limited | 1500 TABLET, FILM COATED in 1 BAG (65862-009-15) | January 14, 2005 |
| 65862-009-26 | 65862-009 | Aurobindo Pharma Limited | 2500 TABLET, FILM COATED in 1 BAG (65862-009-26) | January 14, 2005 |
| 65862-009-33 | 65862-009 | Aurobindo Pharma Limited | 300 TABLET, FILM COATED in 1 BOTTLE (65862-009-33) | January 14, 2005 |
| 65862-009-44 | 65862-009 | Aurobindo Pharma Limited | 2500 TABLET, FILM COATED in 1 BOTTLE (65862-009-44) | January 14, 2005 |
| 65862-009-50 | 65862-009 | Aurobindo Pharma Limited | 50 TABLET, FILM COATED in 1 BOTTLE (65862-009-50) | January 14, 2005 |
| 65862-009-60 | 65862-009 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (65862-009-60) | January 14, 2005 |
| 65862-009-66 | 65862-009 | Aurobindo Pharma Limited | 33000 TABLET, FILM COATED in 1 BAG (65862-009-66) | January 14, 2005 |
| 65862-009-90 | 65862-009 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (65862-009-90) | January 14, 2005 |
| 65862-009-99 | 65862-009 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-009-99) | January 14, 2005 |
| 65862-010-01 | 65862-010 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65862-010-01) | January 14, 2005 |
| 65862-010-05 | 65862-010 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65862-010-05) | January 14, 2005 |
| 65862-010-15 | 65862-010 | Aurobindo Pharma Limited | 1500 TABLET, FILM COATED in 1 BAG (65862-010-15) | January 14, 2005 |
| 65862-010-22 | 65862-010 | Aurobindo Pharma Limited | 2000 TABLET, FILM COATED in 1 BAG (65862-010-22) | January 14, 2005 |
| 65862-010-27 | 65862-010 | Aurobindo Pharma Limited | 27000 TABLET, FILM COATED in 1 BAG (65862-010-27) | January 14, 2005 |
| 65862-010-33 | 65862-010 | Aurobindo Pharma Limited | 300 TABLET, FILM COATED in 1 BOTTLE (65862-010-33) | January 14, 2005 |
| 65862-010-46 | 65862-010 | Aurobindo Pharma Limited | 2000 TABLET, FILM COATED in 1 BOTTLE (65862-010-46) | January 14, 2005 |
| 65862-010-50 | 65862-010 | Aurobindo Pharma Limited | 50 TABLET, FILM COATED in 1 BOTTLE (65862-010-50) | January 14, 2005 |
| 65862-010-60 | 65862-010 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (65862-010-60) | January 14, 2005 |
| 65862-010-90 | 65862-010 | Aurobindo Pharma Limited | 90 TABLET, FILM COATED in 1 BOTTLE (65862-010-90) | January 14, 2005 |
| 65862-010-99 | 65862-010 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-010-99) | January 14, 2005 |
| 71335-2224-0 | 71335-2224 | Bryant Ranch Prepack | 25 TABLET, FILM COATED in 1 BOTTLE (71335-2224-0) | April 3, 2024 |
| 71335-2224-1 | 71335-2224 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2224-1) | August 29, 2023 |
| 71335-2224-2 | 71335-2224 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2224-2) | September 20, 2023 |
| 71335-2224-3 | 71335-2224 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2224-3) | November 16, 2023 |
| 71335-2224-4 | 71335-2224 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2224-4) | April 3, 2024 |
| 71335-2224-5 | 71335-2224 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2224-5) | April 3, 2024 |
| 71335-2224-6 | 71335-2224 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2224-6) | April 3, 2024 |
| 71335-2224-7 | 71335-2224 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-2224-7) | April 3, 2024 |
| 71335-2224-8 | 71335-2224 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2224-8) | September 18, 2023 |
| 71335-2224-9 | 71335-2224 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2224-9) | April 3, 2024 |
| 71335-2533-0 | 71335-2533 | Bryant Ranch Prepack | 1000 TABLET, FILM COATED in 1 BOTTLE (71335-2533-0) | December 10, 2024 |
| 71335-2533-1 | 71335-2533 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2533-1) | December 10, 2024 |
| 71335-2533-2 | 71335-2533 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2533-2) | December 10, 2024 |
| 71335-2533-3 | 71335-2533 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2533-3) | December 10, 2024 |
| 71335-2533-4 | 71335-2533 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2533-4) | December 10, 2024 |
| 71335-2533-5 | 71335-2533 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2533-5) | December 10, 2024 |
| 71335-2533-6 | 71335-2533 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2533-6) | December 10, 2024 |
| 71335-2533-7 | 71335-2533 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-2533-7) | December 10, 2024 |
| 71335-2533-8 | 71335-2533 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2533-8) | December 10, 2024 |
| 71335-2593-1 | 71335-2593 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2593-1) | June 4, 2025 |
| 71335-2593-2 | 71335-2593 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2593-2) | June 4, 2025 |
| 71335-2593-3 | 71335-2593 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2593-3) | June 4, 2025 |
| 71335-2593-4 | 71335-2593 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2593-4) | June 4, 2025 |
| 71335-2593-5 | 71335-2593 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2593-5) | June 4, 2025 |
| 71335-2593-6 | 71335-2593 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2593-6) | June 4, 2025 |
| 71335-3132-0 | 71335-3132 | Bryant Ranch Prepack | 25 TABLET, FILM COATED in 1 BOTTLE (71335-3132-0) | August 26, 2026 |
| 71335-3132-1 | 71335-3132 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3132-1) | August 3, 2026 |
| 71335-3132-2 | 71335-3132 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-3132-2) | July 6, 2026 |
| 71335-3132-3 | 71335-3132 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3132-3) | July 22, 2026 |
| 71335-3132-4 | 71335-3132 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-3132-4) | August 26, 2026 |
| 71335-3132-5 | 71335-3132 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3132-5) | May 12, 2026 |
| 71335-3132-6 | 71335-3132 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-3132-6) | August 26, 2026 |
| 71335-3132-7 | 71335-3132 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-3132-7) | August 26, 2026 |
| 71335-3132-8 | 71335-3132 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-3132-8) | August 26, 2026 |
| 71335-3132-9 | 71335-3132 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-3132-9) | August 26, 2026 |
| 67046-1594-3 | 67046-1594 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1594-3) | September 16, 2025 |
| 42806-313-01 | 42806-313 | Epic Pharma, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (42806-313-01) | March 13, 2017 |
| 42806-313-05 | 42806-313 | Epic Pharma, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (42806-313-05) | March 13, 2017 |
| 42806-313-10 | 42806-313 | Epic Pharma, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-313-10) | March 13, 2017 |
| 42806-314-01 | 42806-314 | Epic Pharma, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (42806-314-01) | March 13, 2017 |
| 42806-314-05 | 42806-314 | Epic Pharma, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (42806-314-05) | March 13, 2017 |
| 42806-314-10 | 42806-314 | Epic Pharma, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-314-10) | March 13, 2017 |
| 42806-315-01 | 42806-315 | Epic Pharma, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (42806-315-01) | March 13, 2017 |
| 42806-315-05 | 42806-315 | Epic Pharma, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (42806-315-05) | March 13, 2017 |
| 42806-315-10 | 42806-315 | Epic Pharma, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-315-10) | March 13, 2017 |
| 42385-947-01 | 42385-947 | Laurus Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42385-947-01) | July 20, 2021 |
| 42385-947-05 | 42385-947 | Laurus Labs Limited | 500 TABLET, FILM COATED in 1 BOTTLE (42385-947-05) | July 20, 2021 |
| 42385-947-11 | 42385-947 | Laurus Labs Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-947-11) | May 17, 2021 |
| 42385-947-18 | 42385-947 | Laurus Labs Limited | 180 TABLET, FILM COATED in 1 BOTTLE (42385-947-18) | July 20, 2021 |
| 42385-947-19 | 42385-947 | Laurus Labs Limited | 10 BLISTER PACK in 1 CARTON (42385-947-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 17, 2021 |
| 42385-947-90 | 42385-947 | Laurus Labs Limited | 90 TABLET, FILM COATED in 1 BOTTLE (42385-947-90) | May 17, 2021 |
| 42385-948-01 | 42385-948 | Laurus Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42385-948-01) | July 20, 2021 |
| 42385-948-05 | 42385-948 | Laurus Labs Limited | 500 TABLET, FILM COATED in 1 BOTTLE (42385-948-05) | July 20, 2021 |
| 42385-948-11 | 42385-948 | Laurus Labs Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-948-11) | May 17, 2021 |
| 42385-948-18 | 42385-948 | Laurus Labs Limited | 180 TABLET, FILM COATED in 1 BOTTLE (42385-948-18) | July 20, 2021 |
| 42385-948-19 | 42385-948 | Laurus Labs Limited | 10 BLISTER PACK in 1 CARTON (42385-948-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 17, 2021 |
| 42385-948-90 | 42385-948 | Laurus Labs Limited | 90 TABLET, FILM COATED in 1 BOTTLE (42385-948-90) | May 17, 2021 |
| 42385-949-01 | 42385-949 | Laurus Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42385-949-01) | July 20, 2021 |
| 42385-949-05 | 42385-949 | Laurus Labs Limited | 500 TABLET, FILM COATED in 1 BOTTLE (42385-949-05) | July 20, 2021 |
| 42385-949-11 | 42385-949 | Laurus Labs Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-949-11) | May 17, 2021 |
| 42385-949-18 | 42385-949 | Laurus Labs Limited | 180 TABLET, FILM COATED in 1 BOTTLE (42385-949-18) | July 20, 2021 |
| 42385-949-19 | 42385-949 | Laurus Labs Limited | 10 BLISTER PACK in 1 CARTON (42385-949-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK | May 17, 2021 |
| 42385-949-60 | 42385-949 | Laurus Labs Limited | 60 TABLET, FILM COATED in 1 BOTTLE (42385-949-60) | May 17, 2021 |
| 42385-949-90 | 42385-949 | Laurus Labs Limited | 90 TABLET, FILM COATED in 1 BOTTLE (42385-949-90) | August 1, 2022 |
| 25000-131-03 | 25000-131 | MARKSANS PHARMA LIMITED | 30 TABLET, FILM COATED in 1 BOTTLE (25000-131-03) | June 1, 2012 |
| 25000-131-12 | 25000-131 | MARKSANS PHARMA LIMITED | 500 TABLET, FILM COATED in 1 BOTTLE (25000-131-12) | June 1, 2012 |
| 25000-131-52 | 25000-131 | MARKSANS PHARMA LIMITED | 1800 TABLET, FILM COATED in 1 BAG (25000-131-52) | June 1, 2012 |
| 25000-131-98 | 25000-131 | MARKSANS PHARMA LIMITED | 1 BAG in 1 BOX (25000-131-98) / 9680 TABLET, FILM COATED in 1 BAG | June 1, 2012 |
| 25000-132-03 | 25000-132 | MARKSANS PHARMA LIMITED | 30 TABLET, FILM COATED in 1 BOTTLE (25000-132-03) | June 1, 2012 |
| 25000-132-12 | 25000-132 | MARKSANS PHARMA LIMITED | 500 TABLET, FILM COATED in 1 BOTTLE (25000-132-12) | June 1, 2012 |
| 25000-132-53 | 25000-132 | MARKSANS PHARMA LIMITED | 1500 TABLET, FILM COATED in 1 BAG (25000-132-53) | June 1, 2012 |
| 25000-132-98 | 25000-132 | MARKSANS PHARMA LIMITED | 1 BAG in 1 BOX (25000-132-98) / 8225 TABLET, FILM COATED in 1 BAG | June 1, 2012 |
| 25000-134-03 | 25000-134 | MARKSANS PHARMA LIMITED | 30 TABLET, FILM COATED in 1 BOTTLE (25000-134-03) | June 1, 2012 |
| 25000-134-14 | 25000-134 | MARKSANS PHARMA LIMITED | 1000 TABLET, FILM COATED in 1 BOTTLE (25000-134-14) | June 1, 2012 |
| 25000-134-51 | 25000-134 | MARKSANS PHARMA LIMITED | 2600 TABLET, FILM COATED in 1 BAG (25000-134-51) | June 1, 2012 |
| 25000-134-98 | 25000-134 | MARKSANS PHARMA LIMITED | 1 BAG in 1 BOX (25000-134-98) / 16455 TABLET, FILM COATED in 1 BAG | June 1, 2012 |
| 33342-141-10 | 33342-141 | Macleods Pharmaceuticals Limited | 90 TABLET, FILM COATED in 1 BOTTLE (33342-141-10) | November 1, 2017 |
| 33342-141-11 | 33342-141 | Macleods Pharmaceuticals Limited | 100 TABLET, FILM COATED in 1 BOTTLE (33342-141-11) | November 1, 2017 |
| 33342-141-44 | 33342-141 | Macleods Pharmaceuticals Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-141-44) | November 1, 2017 |
| 33342-142-10 | 33342-142 | Macleods Pharmaceuticals Limited | 90 TABLET, FILM COATED in 1 BOTTLE (33342-142-10) | November 1, 2017 |
| 33342-142-11 | 33342-142 | Macleods Pharmaceuticals Limited | 100 TABLET, FILM COATED in 1 BOTTLE (33342-142-11) | November 1, 2017 |
| 33342-142-44 | 33342-142 | Macleods Pharmaceuticals Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-142-44) | November 1, 2017 |
| 33342-143-10 | 33342-143 | Macleods Pharmaceuticals Limited | 90 TABLET, FILM COATED in 1 BOTTLE (33342-143-10) | November 1, 2017 |
| 33342-143-11 | 33342-143 | Macleods Pharmaceuticals Limited | 100 TABLET, FILM COATED in 1 BOTTLE (33342-143-11) | November 1, 2017 |
| 33342-143-44 | 33342-143 | Macleods Pharmaceuticals Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-143-44) | November 1, 2017 |
| 71709-110-06 | 71709-110 | Metcure Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (71709-110-06) | November 14, 2017 |
| 71709-110-07 | 71709-110 | Metcure Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (71709-110-07) | November 14, 2017 |
| 71709-111-06 | 71709-111 | Metcure Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (71709-111-06) | November 14, 2017 |
| 71709-111-07 | 71709-111 | Metcure Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (71709-111-07) | November 14, 2017 |
| 71709-112-06 | 71709-112 | Metcure Pharmaceuticals, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (71709-112-06) | November 14, 2017 |
| 71709-112-07 | 71709-112 | Metcure Pharmaceuticals, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (71709-112-07) | November 14, 2017 |
| 0378-7185-05 | 0378-7185 | Mylan Pharmaceuticals Inc. | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7185-05) | June 3, 2010 |
| 0378-7186-05 | 0378-7186 | Mylan Pharmaceuticals Inc. | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7186-05) | June 3, 2010 |
| 0378-7187-05 | 0378-7187 | Mylan Pharmaceuticals Inc. | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7187-05) | June 3, 2010 |
| 0615-8015-05 | 0615-8015 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-05) | January 14, 2005 |
| 0615-8015-28 | 0615-8015 | NCS HealthCare of KY, LLC dba Vangard Labs | 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-28) | April 23, 2024 |
| 0615-8015-30 | 0615-8015 | NCS HealthCare of KY, LLC dba Vangard Labs | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8015-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK | April 24, 2019 |
| 0615-8015-39 | 0615-8015 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8015-39) | January 14, 2005 |
| 0615-8577-39 | 0615-8577 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8577-39) | April 18, 2025 |
| 0615-8578-05 | 0615-8578 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-05) | April 17, 2025 |
| 0615-8578-39 | 0615-8578 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8578-39) | April 17, 2025 |
| 0615-8629-05 | 0615-8629 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8629-05) | March 31, 2026 |
| 0615-8629-28 | 0615-8629 | NCS HealthCare of KY, LLC dba Vangard Labs | 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8629-28) | March 31, 2026 |
| 0615-8629-30 | 0615-8629 | NCS HealthCare of KY, LLC dba Vangard Labs | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8629-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK | April 14, 2026 |
| 0615-8629-39 | 0615-8629 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8629-39) | March 31, 2026 |
| 51655-644-26 | 51655-644 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-644-26) | July 6, 2023 |
| 51655-649-25 | 51655-649 | Northwind Health Company, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-649-25) | July 23, 2025 |
| 51655-649-26 | 51655-649 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-649-26) | June 23, 2023 |
| 51655-649-52 | 51655-649 | Northwind Health Company, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-649-52) | April 1, 2021 |
| 68071-5313-9 | 68071-5313 | NuCare Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68071-5313-9) | August 4, 2026 |
| 68071-5323-6 | 68071-5323 | NuCare Pharmaceuticals, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68071-5323-6) | September 16, 2026 |
| 68071-3833-8 | 68071-3833 | NuCare Pharmaceuticals,Inc. | 180 TABLET, FILM COATED in 1 BOTTLE (68071-3833-8) | April 18, 2025 |
| 68071-5306-6 | 68071-5306 | NuCare Pharmaceuticcals,Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68071-5306-6) | August 17, 2026 |
| 68071-5306-8 | 68071-5306 | NuCare Pharmaceuticcals,Inc. | 180 TABLET, FILM COATED in 1 BOTTLE (68071-5306-8) | June 24, 2026 |
| 72789-551-30 | 72789-551 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-30) | March 13, 2026 |
| 72789-551-42 | 72789-551 | PD-Rx Pharmaceuticals, Inc. | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-42) | February 26, 2026 |
| 72789-551-60 | 72789-551 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-60) | February 26, 2026 |
| 72789-551-90 | 72789-551 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-90) | February 26, 2026 |
| 72789-551-93 | 72789-551 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-93) | February 26, 2026 |
| 72789-561-20 | 72789-561 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-561-20) | April 14, 2026 |
| 72789-561-30 | 72789-561 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-561-30) | April 29, 2026 |
| 72789-561-42 | 72789-561 | PD-Rx Pharmaceuticals, Inc. | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-561-42) | August 4, 2026 |
| 72789-561-60 | 72789-561 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-561-60) | April 16, 2026 |
| 72789-561-90 | 72789-561 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-561-90) | May 27, 2026 |
| 72789-561-93 | 72789-561 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-561-93) | April 16, 2026 |
| 68788-4185-1 | 68788-4185 | Preferred Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68788-4185-1) | August 27, 2026 |
| 68788-4185-3 | 68788-4185 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4185-3) | August 27, 2026 |
| 68788-4185-6 | 68788-4185 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4185-6) | August 27, 2026 |
| 68788-4185-7 | 68788-4185 | Preferred Pharmaceuticals Inc. | 180 TABLET, FILM COATED in 1 BOTTLE (68788-4185-7) | August 27, 2026 |
| 68788-4185-8 | 68788-4185 | Preferred Pharmaceuticals Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (68788-4185-8) | August 27, 2026 |
| 68788-4185-9 | 68788-4185 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4185-9) | August 27, 2026 |
| 68788-8498-1 | 68788-8498 | Preferred Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8498-1) | August 1, 2023 |
| 68788-8498-3 | 68788-8498 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8498-3) | August 1, 2023 |
| 68788-8498-6 | 68788-8498 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8498-6) | August 1, 2023 |
| 68788-8498-7 | 68788-8498 | Preferred Pharmaceuticals Inc. | 180 TABLET, FILM COATED in 1 BOTTLE (68788-8498-7) | August 1, 2023 |
| 68788-8498-8 | 68788-8498 | Preferred Pharmaceuticals Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8498-8) | August 1, 2023 |
| 68788-8498-9 | 68788-8498 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8498-9) | August 1, 2023 |
| 68788-8600-1 | 68788-8600 | Preferred Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8600-1) | March 8, 2024 |
| 68788-8600-3 | 68788-8600 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8600-3) | March 8, 2024 |
| 68788-8600-6 | 68788-8600 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8600-6) | March 8, 2024 |
| 68788-8600-7 | 68788-8600 | Preferred Pharmaceuticals Inc. | 180 TABLET, FILM COATED in 1 BOTTLE (68788-8600-7) | March 8, 2024 |
| 68788-8600-8 | 68788-8600 | Preferred Pharmaceuticals Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8600-8) | March 8, 2024 |
| 68788-8600-9 | 68788-8600 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8600-9) | March 8, 2024 |
| 68788-8756-1 | 68788-8756 | Preferred Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8756-1) | October 14, 2024 |
| 68788-8756-3 | 68788-8756 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8756-3) | October 14, 2024 |
| 68788-8756-6 | 68788-8756 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8756-6) | October 14, 2024 |
| 68788-8756-8 | 68788-8756 | Preferred Pharmaceuticals Inc. | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8756-8) | October 14, 2024 |
| 68788-8756-9 | 68788-8756 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8756-9) | October 14, 2024 |
| 63187-238-30 | 63187-238 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (63187-238-30) | June 16, 2023 |
| 63187-238-60 | 63187-238 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (63187-238-60) | June 16, 2023 |
| 63187-238-78 | 63187-238 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE (63187-238-78) | June 16, 2023 |
| 63187-238-90 | 63187-238 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (63187-238-90) | January 1, 2019 |
| 63187-239-30 | 63187-239 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (63187-239-30) | June 16, 2023 |
| 63187-239-60 | 63187-239 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (63187-239-60) | June 16, 2023 |
| 63187-239-78 | 63187-239 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE (63187-239-78) | June 16, 2023 |
| 63187-239-90 | 63187-239 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (63187-239-90) | January 1, 2019 |
| 71205-783-30 | 71205-783 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-783-30) | March 28, 2023 |
| 71205-783-60 | 71205-783 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-783-60) | March 28, 2023 |
| 71205-783-90 | 71205-783 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-783-90) | March 28, 2023 |
| 71205-784-30 | 71205-784 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-30) | March 29, 2023 |
| 71205-784-60 | 71205-784 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-60) | March 29, 2023 |
| 71205-784-78 | 71205-784 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-78) | March 25, 2024 |
| 71205-784-90 | 71205-784 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-90) | March 29, 2023 |
| 71205-882-00 | 71205-882 | Proficient Rx LP | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-00) | November 8, 2021 |
| 71205-882-11 | 71205-882 | Proficient Rx LP | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-11) | November 8, 2021 |
| 71205-882-30 | 71205-882 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-30) | November 8, 2021 |
| 71205-882-55 | 71205-882 | Proficient Rx LP | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-55) | November 8, 2021 |
| 71205-882-60 | 71205-882 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-60) | November 8, 2021 |
| 71205-882-64 | 71205-882 | Proficient Rx LP | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-64) | November 8, 2021 |
| 71205-882-72 | 71205-882 | Proficient Rx LP | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-72) | November 8, 2021 |
| 71205-882-78 | 71205-882 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-78) | November 8, 2021 |
| 71205-882-90 | 71205-882 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-882-90) | November 8, 2021 |
| 71205-883-00 | 71205-883 | Proficient Rx LP | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-00) | November 8, 2021 |
| 71205-883-11 | 71205-883 | Proficient Rx LP | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-11) | November 8, 2021 |
| 71205-883-30 | 71205-883 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-30) | November 8, 2021 |
| 71205-883-55 | 71205-883 | Proficient Rx LP | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-55) | November 8, 2021 |
| 71205-883-60 | 71205-883 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-60) | November 8, 2021 |
| 71205-883-64 | 71205-883 | Proficient Rx LP | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-64) | November 8, 2021 |
| 71205-883-72 | 71205-883 | Proficient Rx LP | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-72) | November 8, 2021 |
| 71205-883-78 | 71205-883 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-78) | November 8, 2021 |
| 71205-883-90 | 71205-883 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-90) | November 8, 2021 |
| 71205-884-00 | 71205-884 | Proficient Rx LP | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-00) | November 8, 2021 |
| 71205-884-11 | 71205-884 | Proficient Rx LP | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-11) | November 8, 2021 |
| 71205-884-30 | 71205-884 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-30) | November 8, 2021 |
| 71205-884-55 | 71205-884 | Proficient Rx LP | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-55) | November 8, 2021 |
| 71205-884-60 | 71205-884 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-60) | November 8, 2021 |
| 71205-884-64 | 71205-884 | Proficient Rx LP | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-64) | November 8, 2021 |
| 71205-884-72 | 71205-884 | Proficient Rx LP | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-72) | November 8, 2021 |
| 71205-884-78 | 71205-884 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-78) | November 8, 2021 |
| 71205-884-90 | 71205-884 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-884-90) | November 8, 2021 |
| 82804-309-60 | 82804-309 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (82804-309-60) | September 14, 2026 |
| 82804-309-78 | 82804-309 | Proficient Rx LP | 180 TABLET, FILM COATED in 1 BOTTLE (82804-309-78) | August 12, 2026 |
| 24658-790-01 | 24658-790 | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 100 TABLET, FILM COATED in 1 BOTTLE (24658-790-01) | April 1, 2016 |
| 24658-790-10 | 24658-790 | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 1000 TABLET, FILM COATED in 1 BOTTLE (24658-790-10) | April 1, 2016 |
| 24658-791-05 | 24658-791 | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 500 TABLET, FILM COATED in 1 BOTTLE (24658-791-05) | April 1, 2016 |
| 24658-792-05 | 24658-792 | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 500 TABLET, FILM COATED in 1 BOTTLE (24658-792-05) | April 1, 2016 |
| 42708-202-30 | 42708-202 | QPharma Inc | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-202-30) | June 8, 2026 |
| 42708-203-60 | 42708-203 | QPharma,Inc. | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-203-60) | August 20, 2026 |
| 82009-174-10 | 82009-174 | Quallent Pharmaceuticals Health LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-174-10) | July 18, 2025 |
| 82009-175-10 | 82009-175 | Quallent Pharmaceuticals Health LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-175-10) | July 18, 2025 |
| 70518-1149-0 | 70518-1149 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1149-0) | May 1, 2018 |
| 70518-1951-2 | 70518-1951 | REMEDYREPACK INC. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1951-2) | June 1, 2025 |
| 70518-1951-3 | 70518-1951 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-3) | October 28, 2025 |
| 70518-3130-1 | 70518-3130 | REMEDYREPACK INC. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3130-1) | April 22, 2025 |
| 70518-3130-2 | 70518-3130 | REMEDYREPACK INC. | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3130-2) | July 14, 2025 |
| 70518-4262-0 | 70518-4262 | REMEDYREPACK INC. | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4262-0) | January 23, 2025 |
| 69367-180-01 | 69367-180 | Westminster Pharmaceuticals, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-180-01) | November 21, 2017 |
| 69367-180-05 | 69367-180 | Westminster Pharmaceuticals, LLC | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-180-05) | November 21, 2017 |
| 69367-180-10 | 69367-180 | Westminster Pharmaceuticals, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-180-10) | April 21, 2020 |
| 69367-181-01 | 69367-181 | Westminster Pharmaceuticals, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-181-01) | November 21, 2017 |
| 69367-181-05 | 69367-181 | Westminster Pharmaceuticals, LLC | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-181-05) | November 21, 2017 |
| 69367-182-01 | 69367-182 | Westminster Pharmaceuticals, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-01) | November 21, 2017 |
| 69367-182-05 | 69367-182 | Westminster Pharmaceuticals, LLC | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-05) | November 21, 2017 |
| 69367-182-10 | 69367-182 | Westminster Pharmaceuticals, LLC | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-10) | April 21, 2020 |
| 65841-809-01 | 65841-809 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65841-809-01) | December 9, 2014 |
| 65841-809-05 | 65841-809 | Zydus Lifesciences Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65841-809-05) | December 9, 2014 |
| 65841-809-10 | 65841-809 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-809-10) | December 9, 2014 |
| 65841-809-16 | 65841-809 | Zydus Lifesciences Limited | 90 TABLET, FILM COATED in 1 BOTTLE (65841-809-16) | December 9, 2014 |
| 65841-809-77 | 65841-809 | Zydus Lifesciences Limited | 100 BLISTER PACK in 1 CARTON (65841-809-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-809-30) | December 9, 2014 |
| 65841-810-01 | 65841-810 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65841-810-01) | December 9, 2014 |
| 65841-810-05 | 65841-810 | Zydus Lifesciences Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65841-810-05) | December 9, 2014 |
| 65841-810-10 | 65841-810 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-810-10) | December 9, 2014 |
| 65841-810-16 | 65841-810 | Zydus Lifesciences Limited | 90 TABLET, FILM COATED in 1 BOTTLE (65841-810-16) | December 9, 2014 |
| 65841-810-77 | 65841-810 | Zydus Lifesciences Limited | 100 BLISTER PACK in 1 CARTON (65841-810-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-810-30) | December 9, 2014 |
| 65841-811-01 | 65841-811 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65841-811-01) | December 9, 2014 |
| 65841-811-05 | 65841-811 | Zydus Lifesciences Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65841-811-05) | December 9, 2014 |
| 65841-811-10 | 65841-811 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-811-10) | December 9, 2014 |
| 65841-811-16 | 65841-811 | Zydus Lifesciences Limited | 90 TABLET, FILM COATED in 1 BOTTLE (65841-811-16) | December 9, 2014 |
| 65841-811-77 | 65841-811 | Zydus Lifesciences Limited | 100 BLISTER PACK in 1 CARTON (65841-811-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-811-30) | December 9, 2014 |
| 68382-758-01 | 68382-758 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68382-758-01) | December 9, 2014 |
| 68382-758-05 | 68382-758 | Zydus Pharmaceuticals USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (68382-758-05) | December 9, 2014 |
| 68382-758-10 | 68382-758 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-758-10) | December 9, 2014 |
| 68382-758-16 | 68382-758 | Zydus Pharmaceuticals USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68382-758-16) | December 9, 2014 |
| 68382-758-77 | 68382-758 | Zydus Pharmaceuticals USA Inc. | 100 BLISTER PACK in 1 CARTON (68382-758-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-758-30) | December 9, 2014 |
| 68382-759-01 | 68382-759 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68382-759-01) | December 9, 2014 |
| 68382-759-05 | 68382-759 | Zydus Pharmaceuticals USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (68382-759-05) | December 9, 2014 |
| 68382-759-10 | 68382-759 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-759-10) | December 9, 2014 |
| 68382-759-16 | 68382-759 | Zydus Pharmaceuticals USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68382-759-16) | December 9, 2014 |
| 68382-759-77 | 68382-759 | Zydus Pharmaceuticals USA Inc. | 100 BLISTER PACK in 1 CARTON (68382-759-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-759-30) | December 9, 2014 |
| 68382-760-01 | 68382-760 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68382-760-01) | December 9, 2014 |
| 68382-760-05 | 68382-760 | Zydus Pharmaceuticals USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (68382-760-05) | December 9, 2014 |
| 68382-760-10 | 68382-760 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-760-10) | December 9, 2014 |
| 68382-760-16 | 68382-760 | Zydus Pharmaceuticals USA Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68382-760-16) | December 9, 2014 |
| 68382-760-77 | 68382-760 | Zydus Pharmaceuticals USA Inc. | 100 BLISTER PACK in 1 CARTON (68382-760-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-760-30) | December 9, 2014 |
| 50090-2081 | 50090-2081 | A-S Medication Solutions | — | January 14, 2005 |
| 50090-5052 | 50090-5052 | A-S Medication Solutions | — | January 14, 2005 |
| 50090-6485 | 50090-6485 | A-S Medication Solutions | — | January 14, 2005 |
| 50090-6856 | 50090-6856 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-6857 | 50090-6857 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-6858 | 50090-6858 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-6859 | 50090-6859 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-7106 | 50090-7106 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-7107 | 50090-7107 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-7866 | 50090-7866 | A-S Medication Solutions | — | May 17, 2021 |
| 50090-7868 | 50090-7868 | A-S Medication Solutions | — | January 14, 2005 |
| 50090-7877 | 50090-7877 | A-S Medication Solutions | — | August 25, 2025 |
| 50090-7878 | 50090-7878 | A-S Medication Solutions | — | August 25, 2025 |
| 50090-8041 | 50090-8041 | A-S Medication Solutions | — | August 25, 2025 |
| 50090-8043 | 50090-8043 | A-S Medication Solutions | — | August 25, 2025 |
| 80425-0591 | 80425-0591 | Advanced Rx of Tennessee, LLC | — | July 10, 2026 |
| 60687-143 | 60687-143 | American Health Packaging | — | September 9, 2015 |
| 60687-155 | 60687-155 | American Health Packaging | — | April 4, 2016 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.