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Metformin HCl
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 |
|---|---|---|---|---|---|---|---|
| 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 20250725). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [ see Warnings and Precautions ( 5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [ see Dosage and Administration ( 2.3), (2.7), Contraindications ( 4), Warnings and Precautions ( 5.1) ]. If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [ see Warnings and Precautions ( 5.1) ].
Indications and Usage
openFDA Drug LabelingMetformin 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.
Dosage and Administration
openFDA Drug LabelingDOSAGE & ADMINISTRATION There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride or any other pharmacologic agent. Dosage of metformin hydrochloride 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 is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age). Metformin hydrochloride should be given in divided doses with meals. Metformin hydrochloride 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 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, 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 hydrochloride 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 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 2 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 2 weeks. For those patients requiring additional glycemic control, metformin hydrochloride 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. If higher doses of metformin are required, metformin hydrochloride should be used at total daily doses up to 2550 mg administered in divided daily doses, as described above. (See CLINICAL PHARMACOLOGY: Clinical Studies .) Pediatrics – The usual starting dose of metformin hydrochloride 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 hydrochloride, 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 Hydrochloride and Oral Sulfonylurea Therapy in Adult Patients If patients have not responded to four weeks of the maximum dose of metformin hydrochloride monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin hydrochloride at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurre …
Dosage Forms and Strengths
openFDA Drug LabelingMetformin hydrochloride tablets, USP is available as: 500 mg Tablets: white to off white, round, film-coated tablets free from physical defects, debossed with "001" on one side and "500" on the other side. 850 mg Tablets: white to off white, round, film-coated tablets free from physical defects, debossed with "002" on one side and "850" on the other side. 1,000 mg Tablets: white to off white, oval, biconvex, film-coated tablets free from physical defects, debossed with "003" on one side and "1000" on the other side and with a bisect line on both sides.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Metformin Hydrochloride Tablets USP 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 Hydrochloride Tablets USP 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 Labeling5.1 Lactic Acidosis There have been post marketing 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 a treated patient 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 post marketing 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 are 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. 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 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 patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elderly patients. Radiologic studies with contrast — Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis. Stop metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR betwee …
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 USP; 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 USP and by use of the minimum effective dose of Metformin Hydrochloride Tablets USP. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin Hydrochloride Tablets USP 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 USP 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 USP 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 USP, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, Metformin Hydrochloride Tablets USP 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 USP 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 USP, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to …
Adverse Reactions
openFDA Drug LabelingThe 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) ] 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 2,550 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.
Drug Interactions
openFDA Drug LabelingDRUG INTERACTIONS (Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets USP) Glyburide —In a single-dose interaction study in type 2 diabetes patients, coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and C max were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain (see DOSAGE AND ADMINISTRATION: Concomitant Metformin Hydrochloride Tablets USP and Oral Sulfonylurea Therapy in Adult Patients ). Furosemide —A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by coadministration. Furosemide increased the metformin plasma and blood C max by 22% and blood AUC by 15%, without any significant change in metformin renal clearance. When administered with metformin, the C max and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance. No information is available about the interaction of metformin and furosemide when coadministered chronically. Nifedipine —A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that coadministration of nifedipine increased plasma metformin C max and AUC by 20% and 9%, respectively, and increased the amount excreted in the urine. T max and half-life were unaffected. Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine. Cationic drugs —Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no change in elimination half-life in the single-dose study. Metformin had no effect on cimetidine pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of Metformin Hydrochloride Tablets USP and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system. Other —Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Metformin Hydrochloride Tablets USP, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Metformin Hydrochloride Tablets USP, the patient should be observed closely for hypoglycemia. In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies. Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Use in Specific Populations
openFDA Drug Labeling8.1 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 5 times, respectively, a 2,550 mg clinical dose, based on body surface area [ see Data]. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20 to 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 to 4% and 15 to 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 2,550 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 an ovulatory woman. 8.4 Pediatric Use Metformin Hydrochloride Tablets The safety and effectiveness of metformin hydrochloride tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. Safety and effectiveness of metformin hydrochloride tablets have not been established in pe …
Description
openFDA Drug LabelingDESCRIPTION Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: 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. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa 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. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol. Metformin Hydrochloride Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE 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 hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS ). 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, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossed with G;10 on one side and plain on the other side. Bottles of 100 NDC 67877-561-01 Bottles of 500 NDC 67877-561-05 Bottles of 1000 NDC 67877-561-10 850 mg -White to off-white, round, biconvex, film coated tablets debossed with G;11 on one side and plain on the other side. Bottles of 100 NDC 67877-562-01 Bottles of 500 NDC 67877-562-05 Bottles of 1000 NDC 67877-562-10 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossed with G and 12 on either side of the scoreline on one side and plain on the other side. Bottles of 100 NDC 67877-563-01 Bottles of 500 NDC 67877-563-05 Bottles of 1000 NDC 67877-563-10 Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Manufactured by: Granules India Limited, Hyderabad-500081, INDIA MADE IN INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Toll Free No.: 1-877-272-7901 Nov 2016
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.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-3050-0 | 50090-3050 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-3050-0) | July 17, 2017 |
| 50090-3050-2 | 50090-3050 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-3050-2) | June 27, 2017 |
| 50090-3050-4 | 50090-3050 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE, PLASTIC (50090-3050-4) | February 6, 2017 |
| 50090-3050-5 | 50090-3050 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-3050-5) | September 5, 2018 |
| 50090-3064-0 | 50090-3064 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE, PLASTIC (50090-3064-0) | February 6, 2017 |
| 50090-3064-3 | 50090-3064 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-3064-3) | July 13, 2017 |
| 50090-3064-4 | 50090-3064 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-3064-4) | June 16, 2017 |
| 50090-3064-5 | 50090-3064 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE, PLASTIC (50090-3064-5) | February 6, 2017 |
| 50090-3064-6 | 50090-3064 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE, PLASTIC (50090-3064-6) | February 6, 2017 |
| 50090-3579-0 | 50090-3579 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-3579-0) | October 1, 2018 |
| 50090-3579-2 | 50090-3579 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE, PLASTIC (50090-3579-2) | February 6, 2017 |
| 50090-3579-3 | 50090-3579 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3579-3) | February 6, 2017 |
| 50090-3579-4 | 50090-3579 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3579-4) | September 13, 2018 |
| 50090-3579-5 | 50090-3579 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE, PLASTIC (50090-3579-5) | February 6, 2017 |
| 50090-4891-0 | 50090-4891 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-4891-0) | February 13, 2020 |
| 50090-4892-0 | 50090-4892 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-4892-0) | February 13, 2020 |
| 50090-7465-0 | 50090-7465 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7465-0) | November 22, 2024 |
| 50090-7750-0 | 50090-7750 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7750-0) | November 4, 2025 |
| 80425-0435-1 | 80425-0435 | Advanced Rx of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0435-1) | September 3, 2024 |
| 80425-0435-2 | 80425-0435 | Advanced Rx of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0435-2) | September 3, 2024 |
| 80425-0435-3 | 80425-0435 | Advanced Rx of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0435-3) | September 3, 2024 |
| 80425-0435-4 | 80425-0435 | Advanced Rx of Tennessee, LLC | 108 TABLET in 1 BOTTLE (80425-0435-4) | September 3, 2024 |
| 67877-561-01 | 67877-561 | Ascend Laboratories, LLC | 100 TABLET in 1 BOTTLE (67877-561-01) | February 6, 2017 |
| 67877-561-05 | 67877-561 | Ascend Laboratories, LLC | 500 TABLET in 1 BOTTLE (67877-561-05) | February 6, 2017 |
| 67877-561-10 | 67877-561 | Ascend Laboratories, LLC | 1000 TABLET in 1 BOTTLE (67877-561-10) | February 6, 2017 |
| 67877-562-01 | 67877-562 | Ascend Laboratories, LLC | 100 TABLET in 1 BOTTLE (67877-562-01) | February 6, 2017 |
| 67877-562-05 | 67877-562 | Ascend Laboratories, LLC | 500 TABLET in 1 BOTTLE (67877-562-05) | February 6, 2017 |
| 67877-562-10 | 67877-562 | Ascend Laboratories, LLC | 1000 TABLET in 1 BOTTLE (67877-562-10) | February 6, 2017 |
| 67877-563-01 | 67877-563 | Ascend Laboratories, LLC | 100 TABLET in 1 BOTTLE (67877-563-01) | February 6, 2017 |
| 67877-563-05 | 67877-563 | Ascend Laboratories, LLC | 500 TABLET in 1 BOTTLE (67877-563-05) | February 6, 2017 |
| 67877-563-10 | 67877-563 | Ascend Laboratories, LLC | 1000 TABLET in 1 BOTTLE (67877-563-10) | February 6, 2017 |
| 71335-1072-0 | 71335-1072 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-1072-0) | February 1, 2019 |
| 71335-1072-1 | 71335-1072 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1072-1) | February 1, 2019 |
| 71335-1072-2 | 71335-1072 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1072-2) | February 1, 2019 |
| 71335-1072-3 | 71335-1072 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1072-3) | February 1, 2019 |
| 71335-1072-4 | 71335-1072 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1072-4) | February 1, 2019 |
| 71335-1072-5 | 71335-1072 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1072-5) | February 1, 2019 |
| 71335-1072-6 | 71335-1072 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1072-6) | February 1, 2019 |
| 71335-1072-7 | 71335-1072 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1072-7) | February 1, 2019 |
| 71335-1072-8 | 71335-1072 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1072-8) | February 1, 2019 |
| 71335-1072-9 | 71335-1072 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1072-9) | February 1, 2019 |
| 71335-1983-1 | 71335-1983 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1983-1) | November 1, 2021 |
| 71335-1983-2 | 71335-1983 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1983-2) | November 1, 2021 |
| 71335-1983-3 | 71335-1983 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1983-3) | November 1, 2021 |
| 71335-1983-4 | 71335-1983 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1983-4) | November 1, 2021 |
| 71335-1983-5 | 71335-1983 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1983-5) | November 1, 2021 |
| 71335-1983-6 | 71335-1983 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1983-6) | November 1, 2021 |
| 72189-617-30 | 72189-617 | Direct_Rx | 30 TABLET in 1 BOTTLE (72189-617-30) | March 10, 2025 |
| 72189-617-82 | 72189-617 | Direct_Rx | 180 TABLET in 1 BOTTLE (72189-617-82) | March 10, 2025 |
| 72189-635-82 | 72189-635 | Direct_Rx | 180 TABLET in 1 BOTTLE (72189-635-82) | July 25, 2025 |
| 82868-049-60 | 82868-049 | Northwind Health Company, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (82868-049-60) | May 14, 2026 |
| 82868-049-90 | 82868-049 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (82868-049-90) | March 25, 2024 |
| 82868-049-98 | 82868-049 | Northwind Health Company, LLC | 120 TABLET in 1 BOTTLE, PLASTIC (82868-049-98) | February 21, 2024 |
| 68071-3697-1 | 68071-3697 | NuCare Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68071-3697-1) | October 10, 2024 |
| 68071-3541-6 | 68071-3541 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-3541-6) | November 28, 2023 |
| 68071-3541-8 | 68071-3541 | NuCare Pharmaceuticals,Inc. | 180 TABLET in 1 BOTTLE (68071-3541-8) | November 28, 2023 |
| 68071-3541-9 | 68071-3541 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-3541-9) | November 28, 2023 |
| 72789-189-21 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET in 1 BOTTLE, PLASTIC (72789-189-21) | June 15, 2021 |
| 72789-189-30 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-189-30) | May 10, 2021 |
| 72789-189-42 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 42 TABLET in 1 BOTTLE, PLASTIC (72789-189-42) | November 4, 2025 |
| 72789-189-60 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (72789-189-60) | May 25, 2021 |
| 72789-189-90 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-189-90) | May 18, 2021 |
| 72789-189-93 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (72789-189-93) | May 10, 2021 |
| 72789-189-98 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | 120 TABLET in 1 BOTTLE, PLASTIC (72789-189-98) | October 28, 2021 |
| 72789-192-20 | 72789-192 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (72789-192-20) | December 7, 2021 |
| 72789-192-21 | 72789-192 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET in 1 BOTTLE, PLASTIC (72789-192-21) | August 30, 2022 |
| 72789-192-30 | 72789-192 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-192-30) | August 6, 2021 |
| 72789-192-60 | 72789-192 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (72789-192-60) | August 17, 2021 |
| 72789-192-93 | 72789-192 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (72789-192-93) | June 15, 2021 |
| 72789-531-42 | 72789-531 | PD-Rx Pharmaceuticals, Inc. | 42 TABLET in 1 BOTTLE, PLASTIC (72789-531-42) | October 9, 2025 |
| 71205-548-00 | 71205-548 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-548-00) | March 24, 2021 |
| 71205-548-30 | 71205-548 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-548-30) | March 24, 2021 |
| 71205-548-60 | 71205-548 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-548-60) | March 24, 2021 |
| 71205-548-90 | 71205-548 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-548-90) | March 24, 2021 |
| 71205-562-00 | 71205-562 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-562-00) | June 23, 2021 |
| 71205-562-30 | 71205-562 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-562-30) | May 17, 2021 |
| 71205-562-60 | 71205-562 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-562-60) | May 17, 2021 |
| 71205-562-78 | 71205-562 | Proficient Rx LP | 180 TABLET in 1 BOTTLE (71205-562-78) | June 17, 2026 |
| 71205-562-90 | 71205-562 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-562-90) | May 17, 2021 |
| 71205-567-00 | 71205-567 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-567-00) | June 23, 2021 |
| 71205-567-30 | 71205-567 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-567-30) | May 17, 2021 |
| 71205-567-60 | 71205-567 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-567-60) | May 17, 2021 |
| 71205-567-90 | 71205-567 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-567-90) | May 17, 2021 |
| 42708-009-60 | 42708-009 | QPharma, Inc. | 60 TABLET in 1 BOTTLE (42708-009-60) | July 30, 2018 |
| 42708-018-30 | 42708-018 | QPharma, Inc. | 30 TABLET in 1 BOTTLE (42708-018-30) | July 30, 2018 |
| 70518-4479-0 | 70518-4479 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4479-0) | September 13, 2025 |
| 70518-4479-1 | 70518-4479 | REMEDYREPACK INC. | 100 TABLET in 1 BOTTLE, PLASTIC (70518-4479-1) | September 13, 2025 |
| 87441-055-01 | 87441-055 | Unit Dose Solutions, Inc. | 30 TABLET in 1 BLISTER PACK (87441-055-01) | June 26, 2026 |
| 87441-056-01 | 87441-056 | Unit Dose Solutions, Inc. | 30 TABLET in 1 BLISTER PACK (87441-056-01) | June 27, 2026 |
| 50090-3050 | 50090-3050 | A-S Medication Solutions | — | February 6, 2017 |
| 50090-3064 | 50090-3064 | A-S Medication Solutions | — | February 6, 2017 |
| 50090-3579 | 50090-3579 | A-S Medication Solutions | — | February 6, 2017 |
| 50090-4891 | 50090-4891 | A-S Medication Solutions | — | February 6, 2017 |
| 50090-4892 | 50090-4892 | A-S Medication Solutions | — | February 6, 2017 |
| 50090-7465 | 50090-7465 | A-S Medication Solutions | — | February 6, 2017 |
| 50090-7750 | 50090-7750 | A-S Medication Solutions | — | February 6, 2017 |
| 80425-0435 | 80425-0435 | Advanced Rx of Tennessee, LLC | — | September 3, 2024 |
| 67877-561 | 67877-561 | Ascend Laboratories, LLC | — | February 6, 2017 |
| 67877-562 | 67877-562 | Ascend Laboratories, LLC | — | February 6, 2017 |
| 67877-563 | 67877-563 | Ascend Laboratories, LLC | — | February 6, 2017 |
| 71335-1072 | 71335-1072 | Bryant Ranch Prepack | — | February 6, 2017 |
| 71335-1983 | 71335-1983 | Bryant Ranch Prepack | — | February 6, 2017 |
| 72189-617 | 72189-617 | Direct_Rx | — | March 10, 2025 |
| 72189-635 | 72189-635 | Direct_Rx | — | July 25, 2025 |
| 82868-049 | 82868-049 | Northwind Health Company, LLC | — | February 21, 2024 |
| 68071-3697 | 68071-3697 | NuCare Pharmaceuticals, Inc. | — | February 6, 2017 |
| 68071-3541 | 68071-3541 | NuCare Pharmaceuticals,Inc. | — | February 6, 2017 |
| 72789-189 | 72789-189 | PD-Rx Pharmaceuticals, Inc. | — | February 6, 2017 |
| 72789-192 | 72789-192 | PD-Rx Pharmaceuticals, Inc. | — | February 6, 2017 |
| 72789-531 | 72789-531 | PD-Rx Pharmaceuticals, Inc. | — | February 6, 2017 |
| 71205-548 | 71205-548 | Proficient Rx LP | — | February 6, 2017 |
| 71205-562 | 71205-562 | Proficient Rx LP | — | February 6, 2017 |
| 71205-567 | 71205-567 | Proficient Rx LP | — | February 6, 2017 |
| 42708-009 | 42708-009 | QPharma, Inc. | — | February 6, 2017 |
| 42708-018 | 42708-018 | QPharma, Inc. | — | February 6, 2017 |
| 70518-4479 | 70518-4479 | REMEDYREPACK INC. | — | September 13, 2025 |
| 87441-055 | 87441-055 | Unit Dose Solutions, Inc. | — | June 26, 2026 |
| 87441-056 | 87441-056 | Unit Dose Solutions, Inc. | — | June 27, 2026 |
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.