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Metformin Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Metformin Hydrochloride | 1000 mg/1 | 860975 | View |
| Metformin Hydrochloride | 500 mg/1 | 860975 | View |
| Metformin Hydrochloride | 625 mg/1 | 860975 | View |
| Metformin Hydrochloride | 750 mg/1 | 860975 | View |
| Metformin Hydrochloride | 850 mg/1 | 860975 | View |
Forms, 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 |
|---|---|---|---|---|---|---|---|
| 090564-001 | METFORMIN HYDROCHLORIDE | TABLET | METFORMIN HYDROCHLORIDE | Prescription | AB | ||
| 090564-002 | METFORMIN HYDROCHLORIDE | TABLET | METFORMIN HYDROCHLORIDE | Prescription | AB | ||
| 090564-003 | METFORMIN HYDROCHLORIDE | TABLET | METFORMIN HYDROCHLORIDE | Prescription | AB | RS |
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 | 36 | Labeling | Approved | August 11, 2026 | Standard |
| Supplement | 17 | Labeling | Approved | July 2, 2026 | Standard |
| Supplement | 32 | Manufacturing (CMC) | Approved | November 10, 2025 | Unknown |
| Supplement | 15 | Labeling | Approved | February 22, 2019 | Standard |
| Supplement | 13 | Labeling | Approved | August 14, 2017 | Standard |
| Supplement | 12 | Manufacturing (CMC) | Approved | August 14, 2017 | Unknown |
| Supplement | 5 | Manufacturing (CMC) | Approved | April 5, 2016 | Unknown |
| Supplement | 1 | Manufacturing (CMC) | Approved | January 26, 2012 | — |
| Original application | 1 | Approved | April 22, 2010 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260821). 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 hydrochloride tablets; 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 hydrochloride tablets and by use of the minimum effective dose of metformin hydrochloride tablets. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin hydrochloride tablet 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 hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointes …
Recent Major Changes
openFDA Drug LabelingBoxed Warning...................................................04/2026 Warnings and Precautions, Lactic Acidosis ( 5.1 )...............06/2026
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND 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 tablets is 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 )
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. Metformin hydrochloride tablets should be started at a low dose, with gradual dose escalation, both 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 hydrochloride tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three 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 hydrochloride tablets, 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 In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every two weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after two 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 three 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. Transfer from Other Antidiabetic Therapy When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia. Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients If patients have not responded to four weeks of the maximum dose of metformin monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant metformin and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting t …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Metformin Hydrochloride Tablets, USP are available as: Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. Metformin Hydrochloride Tablets, USP 625 mg are blackberry flavored, White to off-white, modified capsule shape film coated tablets, debossed with ‘588’ on one side. Metformin Hydrochloride Tablets, USP 750 mg are blackberry flavored, White to off-white, modified capsule shape film coated tablets, debossed with ‘589’ on one side. Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side. Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. Metformin Hydrochloride Tablets, USP: 500 mg, 625 mg, 750 mg, 850 mg, and 1000 mg ( 3 )
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Metformin hydrochloride tablets are contraindicated in patients with: 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 ). Known hypersensitivity to metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride tablets 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 B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually and vitamin B 12 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. In metformin hydrochloride 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 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, obtain an estimated glomerular filtration rate (eGFR). o Metformin hydrochloride tablets are contraindicated in patients with an eGFR less than 30 mL/ min/1.73 m 2 [see Contraindications (4) ]. o Initiation of metformin hydrochloride tablets is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 . o Obtain an eGFR at least annually in all patients taking metformin hydrochloride tablets. o In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.In patients taking metformin hydrochloride 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 hydrochloride tablets with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation. Consider more frequent monitoring of patients. • Age 65 or greater — The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly pati …
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 hydrochloride tablets; 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 μg/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 hydrochloride tablets and by use of the minimum effective dose of metformin hydrochloride tablets. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of g …
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, 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 ACI Healthcare USA, Inc. at 1-888-802-1213 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 in patients with type 2 diabetes mellitus, a total of 141 patients received Metformin Hydrochloride up to 2550 mg per day. Adverse reactions reported in greater than 5% of Metformin Hydrochloride 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 Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride (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 in 6% of patients. Additionally, the following adverse reactions were reported in ≥1% to ≤5% of Metformin Hydrochloride treated patients and were more commonly reported with Metformin Hydrochloride 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 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. 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 population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
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 in patients with type 2 diabetes mellitus, a total of 141 patients received Metformin Hydrochloride up to 2550 mg per day. Adverse reactions reported in greater than 5% of Metformin Hydrochloride 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 Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride (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 in 6% …
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 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. 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. Insulin Secretagogues or Insulin Clinical Impact: Coadministration of Metformin Hydrochloride 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, 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 Dose of Metformin All metformin and coadministered drugs were given as single doses 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. Cimetidine 400 mg 850 mg metformin 1.40 1.61 Carbonic anhydrase inhibitors may cause metabolic acidosis [See Warnings and Precautions (5.1) ] Topiramate 100 mg At steady state with topiramate 100 mg every 12 hours and metformin 500 mg every 12 hours; AUC = AUC 0-12h 500 mg metformin 1.25 1.17 Table 6: Effect of Metformin on Coadministered Drug Systemic Exposure Coadministered Drug Dose of Coadministered Drug All metformin and c …
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 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 5times, 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 and any potential adverse effects on the breastfed child from Metformin Hydrochloride 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 unintended pregnancy with premenopausal women as therapy with Metformin Hydrochloride Tablets may result in ovulation in some anovulatory women. 8.4 Pediatric Use Metformin Hydrochlorid …
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 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 crystalline compound with a molecular formula of C 4 H 11 N 5 • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The p H of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Formula
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 LabelingHOW SUPPLIED Metformin Hydrochloride Tablets are available as follows: Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. 500 mg: Bottles of 60 NDC 60429-111-60 Bottles of 90 NDC 60429-111-90 Bottles of 100 NDC 60429-111-01 Bottles of 120 NDC 60429-111-12 Bottles of 180 NDC 60429-111-18 Bottles of 270 NDC 60429-111-27 Bottles of 360 NDC 60429-111-36 Bottles of 450 NDC 60429-111-45 Bottles of 1000 NDC 60429-111-10 Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side. 850 mg: Bottles of 60 NDC 60429-112-60 Bottles of 90 NDC 60429-112-90 Bottles of 100 NDC 60429-112-01 Bottles of 180 NDC 60429-112-18 Bottles of 270 NDC 60429-112-27 Bottles of 500 NDC 60429-112-05 Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. 1000 mg: Bottles of 60 NDC 60429-113-60 Bottles of 90 NDC 60429-113-90 Bottles of 180 NDC 60429-113-18 Bottles of 500 NDC 60429-113-05 Bottles of 1000 NDC 60429-113-10 Storage Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Sciegen Pharmaceuticals, Inc Hauppauge, NY 11788 Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012 Rev: 08/13 Rx Only Patient Information METFORMIN HYDROCHLORIDE TABLETS, USP Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine. What are metformin hydrochloride tablets? Metformin hydrochloride tablets are used to treat type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level. High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin hydrochloride tablets, try to control your diabetes by exercise and weight loss. While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes. No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness. Metformin hydrochloride tablets help control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin hydrochloride tablets do not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain. WARNING: A small number of people who have taken metformin hydrochloride tablets have developed a serious condition called lactic acidosis. Lactic acidosi …
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.
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-6507-0 | 50090-6507 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6507-0) | May 31, 2023 |
| 50090-6507-2 | 50090-6507 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6507-2) | May 31, 2023 |
| 50090-6507-3 | 50090-6507 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6507-3) | May 31, 2023 |
| 50090-6507-4 | 50090-6507 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6507-4) | May 31, 2023 |
| 50090-6507-5 | 50090-6507 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-6507-5) | May 31, 2023 |
| 50090-6508-0 | 50090-6508 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6508-0) | May 31, 2023 |
| 50090-6753-0 | 50090-6753 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6753-0) | October 19, 2023 |
| 50090-6753-2 | 50090-6753 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6753-2) | October 17, 2023 |
| 50090-6753-4 | 50090-6753 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6753-4) | October 17, 2023 |
| 50090-6753-5 | 50090-6753 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-6753-5) | October 17, 2023 |
| 50090-6754-0 | 50090-6754 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6754-0) | October 17, 2023 |
| 50090-7010-0 | 50090-7010 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7010-0) | January 4, 2024 |
| 50090-7010-3 | 50090-7010 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7010-3) | January 4, 2024 |
| 50090-7010-4 | 50090-7010 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7010-4) | January 4, 2024 |
| 50090-7010-5 | 50090-7010 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-7010-5) | January 4, 2024 |
| 50090-7010-6 | 50090-7010 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7010-6) | January 4, 2024 |
| 50090-7011-0 | 50090-7011 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7011-0) | January 4, 2024 |
| 50090-7013-0 | 50090-7013 | A-S Medication Solutions | 100 BLISTER PACK in 1 CARTON (50090-7013-0) / 1 TABLET in 1 BLISTER PACK | January 4, 2024 |
| 50090-7586-0 | 50090-7586 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7586-0) | June 30, 2025 |
| 50090-7586-2 | 50090-7586 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7586-2) | June 30, 2025 |
| 50090-7586-3 | 50090-7586 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7586-3) | June 30, 2025 |
| 50090-7586-4 | 50090-7586 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7586-4) | June 30, 2025 |
| 50090-7586-5 | 50090-7586 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-7586-5) | June 30, 2025 |
| 50090-7587-0 | 50090-7587 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7587-0) | June 30, 2025 |
| 50090-7588-0 | 50090-7588 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7588-0) | June 30, 2025 |
| 50090-7595-0 | 50090-7595 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7595-0) | July 7, 2025 |
| 50090-7595-3 | 50090-7595 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7595-3) | July 7, 2025 |
| 50090-7595-4 | 50090-7595 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7595-4) | July 7, 2025 |
| 50090-7595-5 | 50090-7595 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-7595-5) | July 7, 2025 |
| 50090-7595-6 | 50090-7595 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7595-6) | July 7, 2025 |
| 50090-7597-0 | 50090-7597 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7597-0) | July 7, 2025 |
| 71093-132-04 | 71093-132 | ACI Healthcare USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (71093-132-04) | January 15, 2018 |
| 71093-132-05 | 71093-132 | ACI Healthcare USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (71093-132-05) | January 15, 2018 |
| 71093-132-06 | 71093-132 | ACI Healthcare USA, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (71093-132-06) | January 15, 2018 |
| 71093-133-04 | 71093-133 | ACI Healthcare USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (71093-133-04) | January 15, 2018 |
| 71093-133-05 | 71093-133 | ACI Healthcare USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (71093-133-05) | January 15, 2018 |
| 71093-134-04 | 71093-134 | ACI Healthcare USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (71093-134-04) | January 15, 2018 |
| 71093-134-05 | 71093-134 | ACI Healthcare USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (71093-134-05) | January 15, 2018 |
| 53746-218-01 | 53746-218 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE (53746-218-01) | December 17, 2012 |
| 53746-218-05 | 53746-218 | Amneal Pharmaceuticals of New York LLC | 500 TABLET in 1 BOTTLE (53746-218-05) | December 17, 2012 |
| 53746-218-10 | 53746-218 | Amneal Pharmaceuticals of New York LLC | 1000 TABLET in 1 BOTTLE (53746-218-10) | December 17, 2012 |
| 53746-219-01 | 53746-219 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE (53746-219-01) | December 17, 2012 |
| 53746-219-05 | 53746-219 | Amneal Pharmaceuticals of New York LLC | 500 TABLET in 1 BOTTLE (53746-219-05) | December 17, 2012 |
| 53746-219-10 | 53746-219 | Amneal Pharmaceuticals of New York LLC | 1000 TABLET in 1 BOTTLE (53746-219-10) | December 17, 2012 |
| 53746-220-01 | 53746-220 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE (53746-220-01) | December 17, 2012 |
| 53746-220-05 | 53746-220 | Amneal Pharmaceuticals of New York LLC | 500 TABLET in 1 BOTTLE (53746-220-05) | December 17, 2012 |
| 53746-220-10 | 53746-220 | Amneal Pharmaceuticals of New York LLC | 1000 TABLET in 1 BOTTLE (53746-220-10) | December 17, 2012 |
| 43353-982-30 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (43353-982-30) | November 11, 2014 |
| 43353-982-53 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (43353-982-53) | November 16, 2015 |
| 43353-982-60 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (43353-982-60) | May 13, 2015 |
| 43353-982-70 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (43353-982-70) | May 14, 2019 |
| 43353-982-80 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (43353-982-80) | May 12, 2015 |
| 43353-982-92 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (43353-982-92) | May 12, 2015 |
| 43353-982-94 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 360 TABLET in 1 BOTTLE (43353-982-94) | May 12, 2015 |
| 43353-982-96 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | 450 TABLET in 1 BOTTLE (43353-982-96) | March 28, 2015 |
| 43353-987-30 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (43353-987-30) | December 22, 2014 |
| 43353-987-31 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 600 TABLET in 1 BOTTLE (43353-987-31) | June 10, 2024 |
| 43353-987-43 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 1300 TABLET in 1 BOTTLE (43353-987-43) | June 10, 2024 |
| 43353-987-45 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (43353-987-45) | January 5, 2015 |
| 43353-987-53 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (43353-987-53) | February 24, 2015 |
| 43353-987-60 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (43353-987-60) | February 2, 2015 |
| 43353-987-73 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 135 TABLET in 1 BOTTLE (43353-987-73) | December 21, 2014 |
| 43353-987-80 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (43353-987-80) | February 2, 2016 |
| 43353-987-86 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 225 TABLET in 1 BOTTLE (43353-987-86) | December 22, 2014 |
| 43353-987-87 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 2400 TABLET in 1 BOTTLE (43353-987-87) | June 10, 2024 |
| 43353-987-96 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | 450 TABLET in 1 BOTTLE (43353-987-96) | May 13, 2020 |
| 71610-672-30 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-672-30) | November 2, 2022 |
| 71610-672-45 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-672-45) | November 2, 2022 |
| 71610-672-53 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-672-53) | November 2, 2022 |
| 71610-672-60 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-672-60) | November 2, 2022 |
| 71610-672-70 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-672-70) | November 2, 2022 |
| 71610-672-80 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-672-80) | November 2, 2022 |
| 71610-673-30 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-673-30) | November 3, 2022 |
| 71610-673-45 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-673-45) | November 3, 2022 |
| 71610-673-53 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-673-53) | November 3, 2022 |
| 71610-673-60 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-673-60) | November 3, 2022 |
| 71610-673-70 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-673-70) | November 3, 2022 |
| 71610-673-80 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-673-80) | November 3, 2022 |
| 71610-917-30 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-917-30) | June 26, 2025 |
| 71610-917-53 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-917-53) | June 26, 2025 |
| 71610-917-60 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-917-60) | June 26, 2025 |
| 71610-917-70 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-917-70) | June 26, 2025 |
| 71610-917-80 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-917-80) | June 26, 2025 |
| 71610-917-92 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-917-92) | March 25, 2026 |
| 71610-917-94 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | 360 TABLET in 1 BOTTLE (71610-917-94) | June 26, 2025 |
| 71610-918-60 | 71610-918 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-918-60) | July 1, 2025 |
| 71610-918-80 | 71610-918 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-918-80) | June 26, 2025 |
| 71610-918-92 | 71610-918 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-918-92) | June 27, 2025 |
| 71610-923-30 | 71610-923 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-923-30) | July 8, 2025 |
| 71610-923-53 | 71610-923 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-923-53) | July 8, 2025 |
| 71610-923-60 | 71610-923 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-923-60) | July 8, 2025 |
| 71610-923-80 | 71610-923 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-923-80) | July 8, 2025 |
| 71610-923-92 | 71610-923 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-923-92) | July 8, 2025 |
| 71610-937-60 | 71610-937 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-937-60) | August 19, 2025 |
| 71610-937-80 | 71610-937 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-937-80) | August 19, 2025 |
| 63629-8501-1 | 63629-8501 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-8501-1) | May 18, 2021 |
| 63629-8502-1 | 63629-8502 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8502-1) | May 18, 2021 |
| 63629-8503-1 | 63629-8503 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-8503-1) | May 18, 2021 |
| 63629-8504-1 | 63629-8504 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8504-1) | May 18, 2021 |
| 71335-1785-1 | 71335-1785 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE, PLASTIC (71335-1785-1) | March 10, 2021 |
| 71335-1785-2 | 71335-1785 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE, PLASTIC (71335-1785-2) | March 10, 2021 |
| 71335-1785-3 | 71335-1785 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE, PLASTIC (71335-1785-3) | March 10, 2021 |
| 71335-1785-4 | 71335-1785 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE, PLASTIC (71335-1785-4) | March 10, 2021 |
| 71335-1785-5 | 71335-1785 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE, PLASTIC (71335-1785-5) | March 10, 2021 |
| 71335-1785-6 | 71335-1785 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE, PLASTIC (71335-1785-6) | March 10, 2021 |
| 71335-1833-0 | 71335-1833 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (71335-1833-0) | April 29, 2021 |
| 71335-1833-1 | 71335-1833 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1833-1) | April 29, 2021 |
| 71335-1833-2 | 71335-1833 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1833-2) | April 29, 2021 |
| 71335-1833-3 | 71335-1833 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1833-3) | April 29, 2021 |
| 71335-1833-4 | 71335-1833 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1833-4) | April 29, 2021 |
| 71335-1833-5 | 71335-1833 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1833-5) | April 29, 2021 |
| 71335-1833-6 | 71335-1833 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1833-6) | April 29, 2021 |
| 71335-1833-7 | 71335-1833 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1833-7) | April 29, 2021 |
| 71335-1833-8 | 71335-1833 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1833-8) | April 29, 2021 |
| 71335-1834-0 | 71335-1834 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-1834-0) | April 29, 2021 |
| 71335-1834-1 | 71335-1834 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1834-1) | April 29, 2021 |
| 71335-1834-2 | 71335-1834 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1834-2) | April 29, 2021 |
| 71335-1834-3 | 71335-1834 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1834-3) | April 29, 2021 |
| 71335-1834-4 | 71335-1834 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1834-4) | April 29, 2021 |
| 71335-1834-5 | 71335-1834 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1834-5) | April 29, 2021 |
| 71335-1834-6 | 71335-1834 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1834-6) | April 29, 2021 |
| 71335-1834-7 | 71335-1834 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1834-7) | April 29, 2021 |
| 71335-1834-8 | 71335-1834 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1834-8) | April 29, 2021 |
| 71335-1834-9 | 71335-1834 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1834-9) | April 29, 2021 |
| 71335-1835-1 | 71335-1835 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1835-1) | April 29, 2021 |
| 71335-1835-2 | 71335-1835 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1835-2) | April 29, 2021 |
| 71335-1835-3 | 71335-1835 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1835-3) | April 29, 2021 |
| 71335-1835-4 | 71335-1835 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1835-4) | April 29, 2021 |
| 71335-1835-5 | 71335-1835 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1835-5) | April 29, 2021 |
| 71335-1835-6 | 71335-1835 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1835-6) | April 29, 2021 |
| 71335-2245-1 | 71335-2245 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2245-1) | September 25, 2023 |
| 71335-2245-2 | 71335-2245 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2245-2) | September 25, 2023 |
| 71335-2245-3 | 71335-2245 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2245-3) | September 25, 2023 |
| 71335-2245-4 | 71335-2245 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2245-4) | September 25, 2023 |
| 71335-2245-5 | 71335-2245 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2245-5) | September 25, 2023 |
| 71335-2245-6 | 71335-2245 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2245-6) | September 25, 2023 |
| 71335-2466-0 | 71335-2466 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-2466-0) | August 16, 2024 |
| 71335-2466-1 | 71335-2466 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2466-1) | August 16, 2024 |
| 71335-2466-2 | 71335-2466 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2466-2) | August 16, 2024 |
| 71335-2466-3 | 71335-2466 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2466-3) | August 16, 2024 |
| 71335-2466-4 | 71335-2466 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2466-4) | August 16, 2024 |
| 71335-2466-5 | 71335-2466 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2466-5) | August 16, 2024 |
| 71335-2466-6 | 71335-2466 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-2466-6) | August 16, 2024 |
| 71335-2466-7 | 71335-2466 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-2466-7) | August 16, 2024 |
| 71335-2466-8 | 71335-2466 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2466-8) | August 16, 2024 |
| 71335-2466-9 | 71335-2466 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2466-9) | August 16, 2024 |
| 72162-1522-1 | 72162-1522 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1522-1) | February 5, 2024 |
| 72162-1522-5 | 72162-1522 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1522-5) | February 5, 2024 |
| 72162-1523-1 | 72162-1523 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1523-1) | February 5, 2024 |
| 72162-1523-5 | 72162-1523 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1523-5) | February 5, 2024 |
| 55154-4172-0 | 55154-4172 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-4172-0) / 1 TABLET in 1 BLISTER PACK | June 26, 2019 |
| 62135-680-05 | 62135-680 | Chartwell RX, LLC | 500 TABLET in 1 BOTTLE (62135-680-05) | April 6, 2022 |
| 62135-680-10 | 62135-680 | Chartwell RX, LLC | 1000 TABLET in 1 BOTTLE (62135-680-10) | April 6, 2022 |
| 62135-680-18 | 62135-680 | Chartwell RX, LLC | 180 TABLET in 1 BOTTLE (62135-680-18) | April 6, 2022 |
| 62135-680-60 | 62135-680 | Chartwell RX, LLC | 60 TABLET in 1 BOTTLE (62135-680-60) | April 6, 2022 |
| 62135-680-90 | 62135-680 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-680-90) | April 6, 2022 |
| 62135-681-05 | 62135-681 | Chartwell RX, LLC | 500 TABLET in 1 BOTTLE (62135-681-05) | April 6, 2022 |
| 62135-681-30 | 62135-681 | Chartwell RX, LLC | 30 TABLET in 1 BOTTLE (62135-681-30) | April 6, 2022 |
| 62135-681-90 | 62135-681 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-681-90) | April 6, 2022 |
| 62135-682-05 | 62135-682 | Chartwell RX, LLC | 500 TABLET in 1 BOTTLE (62135-682-05) | April 6, 2022 |
| 62135-682-30 | 62135-682 | Chartwell RX, LLC | 30 TABLET in 1 BOTTLE (62135-682-30) | April 6, 2022 |
| 62135-682-90 | 62135-682 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-682-90) | April 6, 2022 |
| 62135-683-05 | 62135-683 | Chartwell RX, LLC | 500 TABLET in 1 BOTTLE (62135-683-05) | April 6, 2022 |
| 62135-683-10 | 62135-683 | Chartwell RX, LLC | 1000 TABLET in 1 BOTTLE (62135-683-10) | April 6, 2022 |
| 62135-683-18 | 62135-683 | Chartwell RX, LLC | 180 TABLET in 1 BOTTLE (62135-683-18) | April 6, 2022 |
| 62135-683-30 | 62135-683 | Chartwell RX, LLC | 30 TABLET in 1 BOTTLE (62135-683-30) | April 6, 2022 |
| 62135-683-90 | 62135-683 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-683-90) | April 6, 2022 |
| 62135-684-05 | 62135-684 | Chartwell RX, LLC | 500 TABLET in 1 BOTTLE (62135-684-05) | April 6, 2022 |
| 62135-684-10 | 62135-684 | Chartwell RX, LLC | 1000 TABLET in 1 BOTTLE (62135-684-10) | April 6, 2022 |
| 62135-684-18 | 62135-684 | Chartwell RX, LLC | 180 TABLET in 1 BOTTLE (62135-684-18) | April 6, 2022 |
| 62135-684-60 | 62135-684 | Chartwell RX, LLC | 60 TABLET in 1 BOTTLE (62135-684-60) | April 6, 2022 |
| 62135-684-90 | 62135-684 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-684-90) | April 6, 2022 |
| 67046-0298-3 | 67046-0298 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0298-3) | May 6, 2026 |
| 67046-0804-3 | 67046-0804 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0804-3) | June 10, 2026 |
| 67046-1516-3 | 67046-1516 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1516-3) | February 6, 2025 |
| 60429-111-01 | 60429-111 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (60429-111-01) | October 23, 2013 |
| 60429-111-10 | 60429-111 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (60429-111-10) | October 23, 2013 |
| 60429-112-01 | 60429-112 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (60429-112-01) | May 1, 2020 |
| 60429-112-05 | 60429-112 | Golden State Medical Supply, Inc. | 500 TABLET in 1 BOTTLE (60429-112-05) | October 23, 2013 |
| 60429-113-01 | 60429-113 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (60429-113-01) | May 1, 2020 |
| 60429-113-05 | 60429-113 | Golden State Medical Supply, Inc. | 500 TABLET in 1 BOTTLE (60429-113-05) | October 23, 2013 |
| 62207-440-43 | 62207-440 | Granules India Ltd | 100 TABLET in 1 BOTTLE (62207-440-43) | July 4, 2019 |
| 62207-440-47 | 62207-440 | Granules India Ltd | 500 TABLET in 1 BOTTLE (62207-440-47) | July 4, 2019 |
| 62207-440-49 | 62207-440 | Granules India Ltd | 1000 TABLET in 1 BOTTLE (62207-440-49) | July 4, 2019 |
| 62207-440-50 | 62207-440 | Granules India Ltd | 60 TABLET in 1 BOTTLE (62207-440-50) | July 4, 2019 |
| 62207-440-57 | 62207-440 | Granules India Ltd | 90 TABLET in 1 BOTTLE (62207-440-57) | July 4, 2019 |
| 62207-440-96 | 62207-440 | Granules India Ltd | 55833 TABLET in 1 DRUM (62207-440-96) | July 4, 2019 |
| 62207-441-43 | 62207-441 | Granules India Ltd | 100 TABLET in 1 BOTTLE (62207-441-43) | July 4, 2019 |
| 62207-441-47 | 62207-441 | Granules India Ltd | 500 TABLET in 1 BOTTLE (62207-441-47) | July 4, 2019 |
| 62207-441-49 | 62207-441 | Granules India Ltd | 1000 TABLET in 1 BOTTLE (62207-441-49) | July 4, 2019 |
| 62207-441-50 | 62207-441 | Granules India Ltd | 60 TABLET in 1 BOTTLE (62207-441-50) | July 4, 2019 |
| 62207-441-57 | 62207-441 | Granules India Ltd | 90 TABLET in 1 BOTTLE (62207-441-57) | July 4, 2019 |
| 62207-441-97 | 62207-441 | Granules India Ltd | 32857 TABLET in 1 DRUM (62207-441-97) | July 4, 2019 |
| 62207-442-43 | 62207-442 | Granules India Ltd | 100 TABLET in 1 BOTTLE (62207-442-43) | July 4, 2019 |
| 62207-442-47 | 62207-442 | Granules India Ltd | 500 TABLET in 1 BOTTLE (62207-442-47) | July 4, 2019 |
| 62207-442-49 | 62207-442 | Granules India Ltd | 1000 TABLET in 1 BOTTLE (62207-442-49) | July 4, 2019 |
| 62207-442-50 | 62207-442 | Granules India Ltd | 60 TABLET in 1 BOTTLE (62207-442-50) | July 4, 2019 |
| 62207-442-57 | 62207-442 | Granules India Ltd | 90 TABLET in 1 BOTTLE (62207-442-57) | July 4, 2019 |
| 62207-442-98 | 62207-442 | Granules India Ltd | 27916 TABLET in 1 DRUM (62207-442-98) | July 4, 2019 |
| 70010-063-15 | 70010-063 | Granules Pharmaceuticals Inc | 55833 TABLET in 1 DRUM (70010-063-15) | June 7, 2019 |
| 70010-064-16 | 70010-064 | Granules Pharmaceuticals Inc | 32857 TABLET in 1 DRUM (70010-064-16) | June 7, 2019 |
| 70010-065-17 | 70010-065 | Granules Pharmaceuticals Inc | 27916 TABLET in 1 DRUM (70010-065-17) | June 7, 2019 |
| 70010-063-01 | 70010-063 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-063-01) | June 26, 2019 |
| 70010-063-05 | 70010-063 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-063-05) | June 26, 2019 |
| 70010-063-06 | 70010-063 | Granules Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (70010-063-06) | June 26, 2019 |
| 70010-063-09 | 70010-063 | Granules Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (70010-063-09) | June 26, 2019 |
| 70010-063-10 | 70010-063 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-063-10) | June 26, 2019 |
| 70010-064-01 | 70010-064 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-064-01) | June 26, 2019 |
| 70010-064-05 | 70010-064 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-064-05) | June 26, 2019 |
| 70010-064-06 | 70010-064 | Granules Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (70010-064-06) | June 26, 2019 |
| 70010-064-09 | 70010-064 | Granules Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (70010-064-09) | June 26, 2019 |
| 70010-064-10 | 70010-064 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-064-10) | June 26, 2019 |
| 70010-064-99 | 70010-064 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-064-99) | August 9, 2023 |
| 70010-065-01 | 70010-065 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-065-01) | June 26, 2019 |
| 70010-065-05 | 70010-065 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-065-05) | June 26, 2019 |
| 70010-065-06 | 70010-065 | Granules Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (70010-065-06) | June 26, 2019 |
| 70010-065-09 | 70010-065 | Granules Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (70010-065-09) | June 26, 2019 |
| 70010-065-10 | 70010-065 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-065-10) | June 26, 2019 |
| 70010-065-99 | 70010-065 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-065-99) | August 9, 2023 |
| 23155-841-01 | 23155-841 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-841-01) | January 19, 2023 |
| 23155-841-05 | 23155-841 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-841-05) | January 19, 2023 |
| 23155-841-10 | 23155-841 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-841-10) | August 30, 2023 |
| 23155-842-01 | 23155-842 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-842-01) | January 19, 2023 |
| 23155-842-05 | 23155-842 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-842-05) | January 19, 2023 |
| 23155-842-10 | 23155-842 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-842-10) | August 30, 2023 |
| 23155-843-01 | 23155-843 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-843-01) | January 19, 2023 |
| 23155-843-05 | 23155-843 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-843-05) | January 19, 2023 |
| 23155-843-10 | 23155-843 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-843-10) | August 30, 2023 |
| 68645-582-59 | 68645-582 | Legacy Pharmaceutical Packaging, LLC | 60 TABLET in 1 BOTTLE (68645-582-59) | June 7, 2019 |
| 68645-583-59 | 68645-583 | Legacy Pharmaceutical Packaging, LLC | 60 TABLET in 1 BOTTLE (68645-583-59) | June 7, 2019 |
| 68645-584-59 | 68645-584 | Legacy Pharmaceutical Packaging, LLC | 60 TABLET in 1 BOTTLE (68645-584-59) | June 7, 2019 |
| 72336-064-30 | 72336-064 | Lifsa Drugs, LLC | 30 TABLET in 1 BOTTLE (72336-064-30) | May 1, 2022 |
| 72336-095-30 | 72336-095 | Lifsa Drugs, LLC | 30 TABLET in 1 BOTTLE (72336-095-30) | January 23, 2025 |
| 0904-7162-61 | 0904-7162 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7162-61) / 1 TABLET in 1 BLISTER PACK | June 26, 2019 |
| 0904-7163-61 | 0904-7163 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7163-61) / 1 TABLET in 1 BLISTER PACK | June 26, 2019 |
| 0904-7164-61 | 0904-7164 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7164-61) / 1 TABLET in 1 BLISTER PACK | June 26, 2019 |
| 58657-726-30 | 58657-726 | Method Pharmaceuticals, LLC. | 30 TABLET in 1 BOTTLE (58657-726-30) | February 9, 2026 |
| 58657-727-30 | 58657-727 | Method Pharmaceuticals, LLC. | 30 TABLET in 1 BOTTLE (58657-727-30) | February 9, 2026 |
| 51655-556-25 | 51655-556 | Northwind Health Company, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (51655-556-25) | September 16, 2022 |
| 51655-556-26 | 51655-556 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-556-26) | August 11, 2022 |
| 51655-556-52 | 51655-556 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-556-52) | September 16, 2022 |
| 51655-566-25 | 51655-566 | Northwind Health Company, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (51655-566-25) | January 27, 2021 |
| 51655-566-26 | 51655-566 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-566-26) | September 15, 2022 |
| 51655-566-52 | 51655-566 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-566-52) | September 16, 2022 |
| 68071-3739-1 | 68071-3739 | NuCare Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68071-3739-1) | December 6, 2024 |
| 68071-3900-6 | 68071-3900 | NuCare Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68071-3900-6) | October 2, 2025 |
| 68071-3495-8 | 68071-3495 | NuCare Pharmaceuticals,Inc. | 180 TABLET in 1 BOTTLE (68071-3495-8) | August 29, 2023 |
| 68071-3518-3 | 68071-3518 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-3518-3) | September 26, 2024 |
| 68071-3518-6 | 68071-3518 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-3518-6) | October 6, 2023 |
| 68071-3518-8 | 68071-3518 | NuCare Pharmaceuticals,Inc. | 180 TABLET in 1 BOTTLE (68071-3518-8) | October 6, 2023 |
| 68071-3518-9 | 68071-3518 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-3518-9) | October 6, 2023 |
| 68071-3526-1 | 68071-3526 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3526-1) | October 23, 2023 |
| 68071-3531-1 | 68071-3531 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3531-1) | November 28, 2023 |
| 68071-3575-8 | 68071-3575 | NuCare Pharmaceuticals,Inc. | 180 TABLET in 1 BOTTLE (68071-3575-8) | February 16, 2024 |
| 43063-527-14 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (43063-527-14) | May 12, 2017 |
| 43063-527-20 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (43063-527-20) | September 16, 2013 |
| 43063-527-30 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-527-30) | September 16, 2013 |
| 43063-527-60 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (43063-527-60) | September 16, 2013 |
| 43063-527-90 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-527-90) | September 16, 2013 |
| 43063-527-93 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (43063-527-93) | September 16, 2013 |
| 43063-527-94 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 270 TABLET in 1 BOTTLE, PLASTIC (43063-527-94) | September 16, 2013 |
| 43063-527-98 | 43063-527 | PD-Rx Pharmaceuticals, Inc. | 120 TABLET in 1 BOTTLE, PLASTIC (43063-527-98) | September 16, 2013 |
| 43063-544-30 | 43063-544 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-544-30) | April 3, 2014 |
| 43063-544-60 | 43063-544 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (43063-544-60) | April 3, 2014 |
| 43063-544-90 | 43063-544 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-544-90) | April 3, 2014 |
| 43063-544-93 | 43063-544 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (43063-544-93) | April 3, 2014 |
| 43063-544-98 | 43063-544 | PD-Rx Pharmaceuticals, Inc. | 120 TABLET in 1 BOTTLE, PLASTIC (43063-544-98) | April 3, 2014 |
| 72789-409-90 | 72789-409 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-409-90) | June 7, 2024 |
| 68788-4076-1 | 68788-4076 | Preferred Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (68788-4076-1) | January 27, 2026 |
| 68788-4076-3 | 68788-4076 | Preferred Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (68788-4076-3) | January 27, 2026 |
| 68788-4076-6 | 68788-4076 | Preferred Pharmaceuticals Inc | 60 TABLET in 1 BOTTLE (68788-4076-6) | January 27, 2026 |
| 68788-4076-7 | 68788-4076 | Preferred Pharmaceuticals Inc | 180 TABLET in 1 BOTTLE (68788-4076-7) | January 27, 2026 |
| 68788-4076-8 | 68788-4076 | Preferred Pharmaceuticals Inc | 120 TABLET in 1 BOTTLE (68788-4076-8) | January 27, 2026 |
| 68788-4076-9 | 68788-4076 | Preferred Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (68788-4076-9) | January 27, 2026 |
| 68788-8430-1 | 68788-8430 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8430-1) | April 26, 2023 |
| 68788-8430-3 | 68788-8430 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8430-3) | April 26, 2023 |
| 68788-8430-6 | 68788-8430 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8430-6) | April 26, 2023 |
| 68788-8430-7 | 68788-8430 | Preferred Pharmaceuticals Inc. | 180 TABLET in 1 BOTTLE (68788-8430-7) | April 26, 2023 |
| 68788-8430-8 | 68788-8430 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-8430-8) | April 26, 2023 |
| 68788-8430-9 | 68788-8430 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8430-9) | April 26, 2023 |
| 68788-8528-1 | 68788-8528 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8528-1) | October 6, 2023 |
| 68788-8528-3 | 68788-8528 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8528-3) | October 6, 2023 |
| 68788-8528-6 | 68788-8528 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8528-6) | October 6, 2023 |
| 68788-8528-8 | 68788-8528 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-8528-8) | October 6, 2023 |
| 68788-8528-9 | 68788-8528 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8528-9) | October 6, 2023 |
| 68788-8560-1 | 68788-8560 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8560-1) | January 8, 2024 |
| 68788-8560-3 | 68788-8560 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8560-3) | January 8, 2024 |
| 68788-8560-6 | 68788-8560 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8560-6) | January 8, 2024 |
| 68788-8560-8 | 68788-8560 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-8560-8) | January 8, 2024 |
| 68788-8560-9 | 68788-8560 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8560-9) | January 8, 2024 |
| 68788-8564-1 | 68788-8564 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8564-1) | January 11, 2024 |
| 68788-8603-1 | 68788-8603 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8603-1) | March 11, 2024 |
| 68788-8603-3 | 68788-8603 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8603-3) | March 11, 2024 |
| 68788-8603-6 | 68788-8603 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8603-6) | March 11, 2024 |
| 68788-8603-8 | 68788-8603 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-8603-8) | March 11, 2024 |
| 68788-8603-9 | 68788-8603 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8603-9) | March 11, 2024 |
| 68788-8652-1 | 68788-8652 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8652-1) | May 3, 2024 |
| 68788-8652-3 | 68788-8652 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8652-3) | May 3, 2024 |
| 68788-8652-6 | 68788-8652 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8652-6) | May 3, 2024 |
| 68788-8652-7 | 68788-8652 | Preferred Pharmaceuticals Inc. | 180 TABLET in 1 BOTTLE (68788-8652-7) | May 3, 2024 |
| 68788-8652-8 | 68788-8652 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-8652-8) | May 3, 2024 |
| 68788-8652-9 | 68788-8652 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8652-9) | May 3, 2024 |
| 71205-555-00 | 71205-555 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-555-00) | June 4, 2021 |
| 71205-555-30 | 71205-555 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-555-30) | April 23, 2021 |
| 71205-555-60 | 71205-555 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-555-60) | April 23, 2021 |
| 71205-555-78 | 71205-555 | Proficient Rx LP | 180 TABLET in 1 BOTTLE (71205-555-78) | December 1, 2021 |
| 71205-555-90 | 71205-555 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-555-90) | April 23, 2021 |
| 71205-622-30 | 71205-622 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-622-30) | November 17, 2021 |
| 71205-622-60 | 71205-622 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-622-60) | November 17, 2021 |
| 71205-622-90 | 71205-622 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-622-90) | November 17, 2021 |
| 82009-046-10 | 82009-046 | Quallent Pharmaceuticals Health LLC | 1000 TABLET in 1 BOTTLE (82009-046-10) | February 1, 2023 |
| 82009-047-10 | 82009-047 | Quallent Pharmaceuticals Health LLC | 1000 TABLET in 1 BOTTLE (82009-047-10) | February 1, 2023 |
| 70518-2833-0 | 70518-2833 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2833-0) | August 14, 2020 |
| 70518-2833-1 | 70518-2833 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2833-1) | July 25, 2022 |
| 70518-2833-2 | 70518-2833 | REMEDYREPACK INC. | 180 TABLET in 1 BOTTLE, PLASTIC (70518-2833-2) | August 3, 2022 |
| 70518-2833-4 | 70518-2833 | REMEDYREPACK INC. | 60 TABLET in 1 BLISTER PACK (70518-2833-4) | September 25, 2023 |
| 70518-2833-5 | 70518-2833 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2833-5) | December 9, 2023 |
| 70518-2833-7 | 70518-2833 | REMEDYREPACK INC. | 100 TABLET in 1 BOTTLE, PLASTIC (70518-2833-7) | March 20, 2025 |
| 70518-2833-9 | 70518-2833 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2833-9) | June 9, 2025 |
| 70518-3084-3 | 70518-3084 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3084-3) | April 16, 2024 |
| 70518-3084-4 | 70518-3084 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3084-4) | May 9, 2024 |
| 70518-3084-6 | 70518-3084 | REMEDYREPACK INC. | 180 TABLET in 1 BOTTLE, PLASTIC (70518-3084-6) | July 16, 2024 |
| 70518-3084-7 | 70518-3084 | REMEDYREPACK INC. | 100 TABLET in 1 BOTTLE, PLASTIC (70518-3084-7) | March 19, 2025 |
| 70518-3101-0 | 70518-3101 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3101-0) | May 24, 2021 |
| 70518-3101-1 | 70518-3101 | REMEDYREPACK INC. | 180 TABLET in 1 BOTTLE, PLASTIC (70518-3101-1) | July 26, 2022 |
| 70518-3101-2 | 70518-3101 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3101-2) | July 29, 2022 |
| 70518-3101-4 | 70518-3101 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3101-4) | March 20, 2024 |
| 70518-3101-5 | 70518-3101 | REMEDYREPACK INC. | 60 TABLET in 1 BOTTLE, PLASTIC (70518-3101-5) | December 9, 2024 |
| 70518-3101-6 | 70518-3101 | REMEDYREPACK INC. | 100 TABLET in 1 BOTTLE, PLASTIC (70518-3101-6) | March 19, 2025 |
| 70518-4698-0 | 70518-4698 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4698-0) | July 14, 2026 |
| 50228-105-00 | 50228-105 | ScieGen Pharmaceuticals Inc | 9000 TABLET in 1 BOTTLE (50228-105-00) | February 1, 2015 |
| 50228-105-01 | 50228-105 | ScieGen Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (50228-105-01) | February 1, 2015 |
| 50228-105-05 | 50228-105 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-105-05) | February 1, 2015 |
| 50228-105-10 | 50228-105 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-105-10) | February 1, 2015 |
| 50228-105-30 | 50228-105 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-105-30) | February 1, 2015 |
| 50228-106-00 | 50228-106 | ScieGen Pharmaceuticals Inc | 4200 TABLET in 1 BOTTLE (50228-106-00) | February 1, 2015 |
| 50228-106-01 | 50228-106 | ScieGen Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (50228-106-01) | February 1, 2015 |
| 50228-106-05 | 50228-106 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-106-05) | February 1, 2015 |
| 50228-106-10 | 50228-106 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-106-10) | February 1, 2015 |
| 50228-106-30 | 50228-106 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-106-30) | February 1, 2015 |
| 50228-107-00 | 50228-107 | ScieGen Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (50228-107-00) | February 1, 2015 |
| 50228-107-01 | 50228-107 | ScieGen Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (50228-107-01) | February 1, 2015 |
| 50228-107-05 | 50228-107 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-107-05) | February 1, 2015 |
| 50228-107-10 | 50228-107 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-107-10) | February 1, 2015 |
| 50228-107-30 | 50228-107 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-107-30) | February 1, 2015 |
| 50228-107-60 | 50228-107 | ScieGen Pharmaceuticals Inc | 60 TABLET in 1 BOTTLE (50228-107-60) | December 26, 2022 |
| 50228-588-05 | 50228-588 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-588-05) | August 21, 2026 |
| 50228-588-30 | 50228-588 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-588-30) | August 21, 2026 |
| 50228-589-05 | 50228-589 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-589-05) | August 21, 2026 |
| 50228-589-30 | 50228-589 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-589-30) | August 21, 2026 |
| 87441-054-01 | 87441-054 | Unit Dose Solutions, Inc. | 30 TABLET in 1 BLISTER PACK (87441-054-01) | June 26, 2026 |
| 72189-219-30 | 72189-219 | direct rx | 30 TABLET in 1 BOTTLE (72189-219-30) | May 26, 2021 |
| 72189-219-60 | 72189-219 | direct rx | 60 TABLET in 1 BOTTLE (72189-219-60) | May 26, 2021 |
| 72189-219-82 | 72189-219 | direct rx | 180 TABLET in 1 BOTTLE (72189-219-82) | May 26, 2021 |
| 72189-219-90 | 72189-219 | direct rx | 90 TABLET in 1 BOTTLE (72189-219-90) | May 26, 2021 |
| 72189-220-30 | 72189-220 | direct rx | 30 TABLET in 1 BOTTLE (72189-220-30) | May 27, 2021 |
| 72189-220-60 | 72189-220 | direct rx | 60 TABLET in 1 BOTTLE (72189-220-60) | May 27, 2021 |
| 72189-220-82 | 72189-220 | direct rx | 180 TABLET in 1 BOTTLE (72189-220-82) | May 27, 2021 |
| 72189-220-90 | 72189-220 | direct rx | 90 TABLET in 1 BOTTLE (72189-220-90) | May 27, 2021 |
| 72189-221-60 | 72189-221 | direct rx | 60 TABLET in 1 BOTTLE (72189-221-60) | June 1, 2021 |
| 72189-221-82 | 72189-221 | direct rx | 180 TABLET in 1 BOTTLE (72189-221-82) | June 1, 2021 |
| 72189-221-90 | 72189-221 | direct rx | 90 TABLET in 1 BOTTLE (72189-221-90) | June 1, 2021 |
| 50090-6507 | 50090-6507 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-6508 | 50090-6508 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-6753 | 50090-6753 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-6754 | 50090-6754 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-7010 | 50090-7010 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-7011 | 50090-7011 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-7013 | 50090-7013 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-7586 | 50090-7586 | A-S Medication Solutions | — | February 1, 2015 |
| 50090-7587 | 50090-7587 | A-S Medication Solutions | — | February 1, 2015 |
| 50090-7588 | 50090-7588 | A-S Medication Solutions | — | February 1, 2015 |
| 50090-7595 | 50090-7595 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-7597 | 50090-7597 | A-S Medication Solutions | — | June 26, 2019 |
| 71093-132 | 71093-132 | ACI Healthcare USA, Inc. | — | January 15, 2018 |
| 71093-133 | 71093-133 | ACI Healthcare USA, Inc. | — | January 15, 2018 |
| 71093-134 | 71093-134 | ACI Healthcare USA, Inc. | — | January 15, 2018 |
| 53746-218 | 53746-218 | Amneal Pharmaceuticals of New York LLC | — | December 17, 2012 |
| 53746-219 | 53746-219 | Amneal Pharmaceuticals of New York LLC | — | December 17, 2012 |
| 53746-220 | 53746-220 | Amneal Pharmaceuticals of New York LLC | — | December 17, 2012 |
| 43353-982 | 43353-982 | Aphena Pharma Solutions - Tennessee, LLC | — | September 11, 2013 |
| 43353-987 | 43353-987 | Aphena Pharma Solutions - Tennessee, LLC | — | September 11, 2013 |
| 71610-672 | 71610-672 | Aphena Pharma Solutions - Tennessee, LLC | — | February 1, 2015 |
| 71610-673 | 71610-673 | Aphena Pharma Solutions - Tennessee, LLC | — | June 26, 2019 |
| 71610-917 | 71610-917 | Aphena Pharma Solutions - Tennessee, LLC | — | February 1, 2015 |
| 71610-918 | 71610-918 | Aphena Pharma Solutions - Tennessee, LLC | — | February 1, 2015 |
| 71610-923 | 71610-923 | Aphena Pharma Solutions - Tennessee, LLC | — | September 11, 2013 |
| 71610-937 | 71610-937 | Aphena Pharma Solutions - Tennessee, LLC | — | January 19, 2023 |
| 63629-8501 | 63629-8501 | Bryant Ranch Prepack | — | February 1, 2015 |
| 63629-8502 | 63629-8502 | Bryant Ranch Prepack | — | February 1, 2015 |
| 63629-8503 | 63629-8503 | Bryant Ranch Prepack | — | February 1, 2015 |
| 63629-8504 | 63629-8504 | Bryant Ranch Prepack | — | February 1, 2015 |
| 71335-1785 | 71335-1785 | Bryant Ranch Prepack | — | January 15, 2018 |
| 71335-1833 | 71335-1833 | Bryant Ranch Prepack | — | February 1, 2015 |
| 71335-1834 | 71335-1834 | Bryant Ranch Prepack | — | February 1, 2015 |
| 71335-1835 | 71335-1835 | Bryant Ranch Prepack | — | February 1, 2015 |
| 71335-2245 | 71335-2245 | Bryant Ranch Prepack | — | January 19, 2023 |
| 71335-2466 | 71335-2466 | Bryant Ranch Prepack | — | January 19, 2023 |
| 72162-1522 | 72162-1522 | Bryant Ranch Prepack | — | February 1, 2015 |
| 72162-1523 | 72162-1523 | Bryant Ranch Prepack | — | February 1, 2015 |
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 |
Generated September 25, 2026 · 12 sections on this page.