Metformin hydrochloride
Tablet, Extended Release · Oral
Uses
Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Dosage and administration
Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 mg once daily with the evening meal. ( 2.1 ) Patients receiving metformin hydrochloride (HCl) tablets may be switched to Metformin Hydrochloride Extended-Release Tablets once daily at the same total daily dose, up to 2,000 mg once daily. ( 2.1 ) Swallow Metformin Hydrochloride Extended-Release Tablets whole and never crush, cut or chew. ( 2.1 ) Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR). ( 2.2 ) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 . Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . Assess risk/benefit of continuing Metformin Hydrochloride Extended-Release Tablets if eGFR falls below 45 mL/minute/1.73 m 2 . Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 . Discontinuation for Iodinated Contrast Imaging Procedures: Metformin Hydrochloride Extended-Release Tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ( 2.3 ) 2.1 Adult Dosage and Administration The recommended starting dose of Metformin Hydrochloride Extended-Release Tablets is 500 mg orally once daily with the evening meal. Increase the dose in increments of 500 mg every 1 to 2 weeks on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg once daily with the evening meal. Patients receiving metformin hydrochloride (HCl) may be switched to Metformin Hydrochloride Extended-Release Tablets once daily at the same total daily dose, up to 2,000 mg once daily. Swallow Metformin Hydrochloride Extended-Release Tablets whole and never crush, cut or chew. If a dose of Metformin Hydrochloride Extended-Release Tablets is missed, instruct patients not to take two doses the same day and to resume their usual dose of Metformin Hydrochloride Extended-Release Tablets with the next schedule dose. 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of Metformin Hydrochloride Extended-Release Tablets and periodically thereafter. Metformin Hydrochloride Extended-Release Tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of Metformin Hydrochloride Extended-Release Tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. In patients taking Metformin Hydrochloride Extended-Release Tablets whose eGFR later falls below 45 mL/minute/1.73 m 2 , assess the benefit risk of continuing therapy. Discontinue Metformin Hydrochloride Extended-Release Tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . 2.3 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue Metformin Hydrochloride Extended-Release Tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Metformin Hydrochloride Extended-Release Tablets if renal function is stable [see Warnings and Precautions ( 5.1 )].
Dosage forms and strengths
Metformin Hydrochloride Extended-Release Tablets are available as: Extended-release tablets: 500 mg white, film-coated, oval-shaped tablets with “M500” on one side. Extended-release tablets : 1,000 mg white, film-coated, oval-shaped tablets with “M1000” on one side. Metformin Hydrochloride Extended-Release Tablets: 500 mg and 1,000 mg ( 3 )
Contraindications
Metformin Hydrochloride Extended-Release Tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/minute/1.73 m 2 ) [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to metformin. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Severe renal impairment: (eGFR below 30 mL/minute/1.73 m 2 ) ( 4 , 5.1 ) Known hypersensitivity to metformin ( 4 ) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma ( 4 )
Warnings and precautions
Lactic Acidosis : See boxed warning. ( 5.1 ) Vitamin B 12 Deficiency : Metformin may lower vitamin B 12 levels. Monitor 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, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/Liter), 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 Extended-Release Tablets. In Metformin Hydrochloride Extended-Release Tablets-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin HCl is dialyzable, with a clearance of up to 170 mL/minute 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 Extended-Release Tablets and report these symptoms to their healthcare provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: Renal Impairment: The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]: Before initiating Metformin Hydrochloride Extended-Release Tablets, obtain an estimated glomerular filtration rate (eGFR). Metformin Hydrochloride Extended-Release Tablets are contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m 2 [see Contraindications ( 4 )]. Initiation of Metformin Hydrochloride Extended-Release Tablets is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . Obtain an eGFR at least annually in all patients taking Metformin Hydrochloride Extended-Release Tablets. In patients at increased risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently. In patients taking Metformin Hydrochloride Extended-Release Tablets whose eGFR later falls below 45 mL/minute/1.73 m 2 , assess the benefit and risk of continuing therapy. Drug Interactions: The concomitant use of Metformin Hydrochloride Extended-Release 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 [see Drug Interactions ( 7 )]. Therefore, 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 [see Use in Specific Populations ( 8.5 )]. Radiological 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 Extended-Release Tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and restart Metformin Hydrochloride Extended-Release Tablets if renal function is stable. Surgery and Other Procedures: Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension and renal impairment. Metformin Hydrochloride Extended-Release Tablets should be temporarily discontinued while patients have restricted food and fluid intake. Hypoxic States: Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur, discontinue Metformin Hydrochloride Extended-Release Tablets.
Side effects
The following adverse reactions are discussed in more detail in other sections of 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 )] Adverse reactions occurring >5% in Metformin Hydrochloride Extended-Release Tablets clinical trials: hypoglycemia, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. In clinical trials conducted in the U.S., over 1,000 patients with type 2 diabetes mellitus have been treated with Metformin Hydrochloride Extended-Release Tablets 1,500 to 2,000 mg/day in active-controlled and placebo-controlled studies with the 500 mg dosage form. In the add-on to sulfonylurea study, patients receiving background glyburide therapy were randomized to receive add-on treatment of either one of three different regimens of Metformin Hydrochloride Extended-Release Tablets or placebo. In total, 431 patients received Metformin Hydrochloride Extended-Release Tablets and glyburide and 144 patients received placebo and glyburide. Adverse reactions reported in greater than 5% of patients treated with Metformin Hydrochloride Extended-Release Tablets that were more common in the combined Metformin Hydrochloride Extended-Release Tablets and glyburide group than in the placebo and glyburide group are shown in Table 1. In 0.7% of patients treated with Metformin Hydrochloride Extended-Release Tablets and glyburide, diarrhea was responsible for discontinuation of study medication compared to no patients in the placebo and glyburide group. Table 1: Adverse Reactions Reported by >5% Adverse reactions that were more common in the Metformin Hydrochloride Extended-Release Tablets-treated than in the placebo-treated patients. of Patients for the Combined Metformin Hydrochloride Extended-Release Tablets Groups Versus Placebo Group Adverse Reaction Metformin Hydrochloride Extended-Release Tablets + Glyburide (n=431) Placebo + Glyburide (n=144) Hypoglycemia 14% 5% Diarrhea 13% 6% Nausea 7% 4% Laboratory Tests Vitamin B 12 Concentrations In clinical trials of 29-week duration with metformin HCl tablets, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Metformin Hydrochloride Extended-Release Tablets. 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
Table 2 presents clinically significant drug interactions with Metformin Hydrochloride Extended-Release Tablets. Table 2: Clinically Significant Drug Interactions with Metformin Hydrochloride Extended-Release 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 Extended-Release Tablets may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce Metformin Hydrochloride Extended-Release Tablets 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 Extended-Release Tablets. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of metformin on lactate metabolism. Intervention: Warn patients against excessive alcohol intake while receiving Metformin Hydrochloride Extended-Release Tablets. Insulin Secretagogues or Insulin Clinical Impact: Coadministration of Metformin Hydrochloride Extended-Release Tablets with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia. Intervention: Patients receiving an insulin secretagogue or insulin may require lower doses of the insulin secretagogue or insulin. Drugs Affecting Glycemic Control Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. Intervention: When such drugs are administered to a patient receiving Metformin Hydrochloride Extended-Release Tablets, observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Metformin Hydrochloride Extended-Release 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 )
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 Extended-Release Tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see Data] . The estimated background risk of major birth defects is 6–10% in women with pregestational diabetes mellitus with an HbA1c >7 and has been reported to be as high as 20–25% in women with an 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 postmarketing 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 HCl was not teratogenic or embyrolethal when administered to rats prior to pregnancy through the period of organogenesis at doses up to 900 mg/kg, or when administered to rabbits during the period of organogenesis at doses up to 90 mg/kg. 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 Extended-Release Tablets and any potential adverse effects on the breastfed child from Metformin Hydrochloride Extended-Release Tablets or from the underlying maternal condition. Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. 8.3 Females and Males of Reproductive Potential Discuss the potential for unintended pregnancy with premenopausal women as therapy with Metformin Hydrochloride Extended-Release Tablets may result in ovulation in some anovulatory women. 8.4 Pediatric Use Safety and effectiveness of Metformin Hydrochloride Extended-Release Tablets in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of Metformin Hydrochloride Extended-Release Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients. [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 ).] 8.6 Renal Impairment Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. Metformin Hydrochloride Extended-Release Tablets are contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Clinical Pharmacology ( 12.3 ).] 8.7 Hepatic Impairment Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. Metformin Hydrochloride Extended-Release Tablets are not recommended in patients with hepatic impairment . [see Warnings and Precautions ( 5.1 ).]
Pregnancy
8.1 Pregnancy Risk Summary Limited data with Metformin Hydrochloride Extended-Release Tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see Data] . The estimated background risk of major birth defects is 6–10% in women with pregestational diabetes mellitus with an HbA1c >7 and has been reported to be as high as 20–25% in women with an 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 postmarketing 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 HCl was not teratogenic or embyrolethal when administered to rats prior to pregnancy through the period of organogenesis at doses up to 900 mg/kg, or when administered to rabbits during the period of organogenesis at doses up to 90 mg/kg.
Pediatric use
8.4 Pediatric Use Safety and effectiveness of Metformin Hydrochloride Extended-Release Tablets in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use Clinical studies of Metformin Hydrochloride Extended-Release Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients. [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 ).]
Overdosage
Overdose of metformin HCl 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/minute under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
Description
Metformin Hydrochloride Extended-Release Tablets contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. 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 Extended-Release Tablets contain 500 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each 500 mg tablet contains coloring, hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene oxide. Each 1,000 mg tablet contains colloidal silicon dioxide, polyvinyl alcohol, crospovidone, glyceryl behenate, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, eudragit, titanium dioxide, simethicone emulsion, polysorbate and coloring. Chemical Structure-Glumetza
Mechanism of action
12.1 Mechanism of Action Metformin is a biguanide that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.
How supplied
Metformin Hydrochloride Extended-Release Tablets are supplied as: 500 mg Bottles of 100 NDC 68682-021-50 white, film-coated, oval-shaped, extended-release tablets with “M500” on one side. 1,000 mg Bottles of 90 NDC 68682-018-90 white, film-coated, oval-shaped, extended-release tablets with “M1000” on one side. 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].
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Lactic Acidosis : Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue Metformin Hydrochloride Extended-Release Tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving Metformin Hydrochloride Extended-Release Tablets. Instruct patients to inform their doctor that they are taking Metformin Hydrochloride Extended-Release Tablets prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions ( 5.1 )] . Hypoglycemia Inform patients that hypoglycemia may occur when Metformin Hydrochloride Extended-Release Tablets are coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions ( 5.3 )] . Vitamin B12 Deficiency: Inform patients about importance of regular hematological parameters while receiving Metformin Hydrochloride Extended-Release Tablets [see Warnings and Precautions ( 5.2 )] . Females of Reproductive Age: Inform females that treatment with Metformin Hydrochloride Extended-Release Tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations ( 8.3 )] . Administration Information: Inform patients that Metformin Hydrochloride Extended-Release Tablets must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada U.S. Patent Numbers: 6,488,962; 6,723,340; 7,780,987 and 8,323,692 © 2019 Bausch Health Companies Inc. or its affiliates 9619003 20002705
Label text from the FDA structured product label by Oceanside Pharmaceuticals (revised Nov 14, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Metformin Hydrochloride in 373 products
Metformin hydrochloride NDC products (373)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7579 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5396 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5246 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5052 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2081 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1494 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7534 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7535 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7576 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7577 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7578 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-5397 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7586 | Metformin Hydrochloride 1000 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7587 | Metformin Hydrochloride 1000 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7588 | Metformin Hydrochloride 1000 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7595 | Metformin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7597 | Metformin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7866 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7877 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7878 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7918 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6859 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7455 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-7454 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-7280 | Metformin Hydrochloride 500 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-7278 | Metformin Hydrochloride 500 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-7116 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-7107 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7106 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7013 | Metformin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7011 | Metformin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7010 | Metformin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7868 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6858 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6857 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6856 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6839 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6754 | Metformin Hydrochloride 850 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6753 | Metformin Hydrochloride 850 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6508 | Metformin Hydrochloride 1000 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6507 | Metformin Hydrochloride 1000 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6485 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-8043 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-8041 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 71093-134 | Metformin Hydrochloride 1000 mg/1 Tablet | ACI Healthcare USA, Inc. | ANDA |
| 71093-133 | Metformin Hydrochloride 850 mg/1 Tablet | ACI Healthcare USA, Inc. | ANDA |
| 71093-132 | Metformin Hydrochloride 500 mg/1 Tablet | ACI Healthcare USA, Inc. | ANDA |
| 80425-0591 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA |
| 11788-038 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated, Extended Release | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-037 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated, Extended Release | AiPing Pharmaceutical, Inc. | ANDA |
| 27241-240 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-188 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-189 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-241 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 60687-143 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-155 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-162 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 65162-178 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 65162-179 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 69238-2126 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 69238-2125 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 53746-219 | Metformin Hydrochloride 850 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-220 | Metformin Hydrochloride 1000 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-218 | Metformin Hydrochloride 500 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 71610-666 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-447 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-533 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-554 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-578 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-587 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-740 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-918 | Metformin Hydrochloride 850 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-917 | Metformin Hydrochloride 500 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-867 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-858 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-941 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-652 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-837 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-673 | Metformin Hydrochloride 1000 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-937 | Metformin Hydrochloride 1000 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-929 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-982 | Metformin Hydrochloride 500 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-987 | Metformin Hydrochloride 1000 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-923 | Metformin Hydrochloride 850 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-920 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-672 | Metformin Hydrochloride 1000 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-218 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-217 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-159 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-221 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-413 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-414 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-932 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-931 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-930 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 59651-043 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 65862-008 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-009 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-010 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-042 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 59651-548 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 59651-549 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 59651-854 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-855 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-856 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 42291-825 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | AvKARE | ANDA |
| 42291-824 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | AvKARE | ANDA |
| 50268-551 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | AvPAK | ANDA |
| 50268-550 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | AvPAK | ANDA |
| 71335-9683 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-9752 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-8504 | Metformin Hydrochloride 1000 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8502 | Metformin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8503 | Metformin Hydrochloride 1000 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0886 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3166 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-3132 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-8501 | Metformin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-5934 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2504 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2533 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2568 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2593 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1834 | Metformin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1785 | Metformin Hydrochloride 850 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0776 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9147 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1833 | Metformin Hydrochloride 1000 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0720 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1835 | Metformin Hydrochloride 850 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1293 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2224 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2245 | Metformin Hydrochloride 850 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2466 | Metformin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1522 | Metformin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1523 | Metformin Hydrochloride 1000 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 31722-042 | Metformin Hydrochloride 500 mg/5mL Solution | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-4172 | Metformin Hydrochloride 500 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 62135-681 | Metformin Hydrochloride 625 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-680 | Metformin Hydrochloride 500 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-683 | Metformin Hydrochloride 850 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-684 | Metformin Hydrochloride 1000 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-682 | Metformin Hydrochloride 750 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 67046-0804 | Metformin Hydrochloride 850 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1594 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1556 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 67046-1516 | Metformin Hydrochloride 1000 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-0298 | Metformin Hydrochloride 500 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1554 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | Coupler, LLC | ANDA |
| 72189-219 | Metformin Hydrochloride 500 mg/1 Tablet | direct rx | ANDA |
| 72189-220 | Metformin Hydrochloride 1000 mg/1 Tablet | direct rx | ANDA |
| 72189-221 | Metformin Hydrochloride 850 mg/1 Tablet | direct rx | ANDA |
| 72189-150 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | direct rx | ANDA |
| 42806-632 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 42806-313 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Epic Pharma, LLC | ANDA |
| 42806-314 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Epic Pharma, LLC | ANDA |
| 42806-315 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Epic Pharma, LLC | ANDA |
| 42806-405 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated, Extended Release | EPIC PHARMA, LLC | ANDA |
| 42806-406 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated, Extended Release | EPIC PHARMA, LLC | ANDA |
| 42806-633 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Epic Pharma, LLC | ANDA |
| 68462-520 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated, Extended Release | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 68462-521 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated, Extended Release | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 60429-113 | Metformin Hydrochloride 1000 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-059 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 60429-111 | Metformin Hydrochloride 500 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 60429-112 | Metformin Hydrochloride 850 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 62207-497 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-496 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-442 | Metformin Hydrochloride 1000 mg/1 Tablet | Granules India Ltd | ANDA |
| 62207-441 | Metformin Hydrochloride 850 mg/1 Tablet | Granules India Ltd | ANDA |
| 62207-440 | Metformin Hydrochloride 500 mg/1 Tablet | Granules India Ltd | ANDA |
| 70010-497 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Granules Pharmaceuticals Inc. | ANDA |
| 70010-496 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Granules Pharmaceuticals Inc. | ANDA |
| 70010-065 | Metformin Hydrochloride 1000 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA |
| 70010-063 | Metformin Hydrochloride 500 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA |
| 70010-064 | Metformin Hydrochloride 850 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA |
| 23155-841 | Metformin Hydrochloride 500 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-842 | Metformin Hydrochloride 850 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-843 | Metformin Hydrochloride 1000 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 42385-947 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 42385-948 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 42385-949 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 42385-977 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Laurus Labs Limited | ANDA |
| 42385-978 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Laurus Labs Limited | ANDA |
| 69315-410 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Leading Pharma, LLC | ANDA |
| 68645-584 | Metformin Hydrochloride 1000 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 68645-583 | Metformin Hydrochloride 850 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 68645-582 | Metformin Hydrochloride 500 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 72336-064 | Metformin Hydrochloride 625 mg/1 Tablet | Lifsa Drugs, LLC | ANDA |
| 72336-095 | Metformin Hydrochloride 750 mg/1 Tablet | Lifsa Drugs, LLC | ANDA |
| 68180-336 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-337 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-338 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-339 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-141 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-142 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-143 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-239 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-240 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-378 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 0904-7162 | Metformin Hydrochloride 500 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7164 | Metformin Hydrochloride 1000 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7163 | Metformin Hydrochloride 850 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 25000-134 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | MARKSANS PHARMA LIMITED | ANDA |
| 25000-132 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | MARKSANS PHARMA LIMITED | ANDA |
| 25000-131 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | MARKSANS PHARMA LIMITED | ANDA |
| 25000-102 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | MARKSANS PHARMA LIMITED | ANDA |
| 25000-101 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | MARKSANS PHARMA LIMITED | ANDA |
| 10135-824 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Marlex Pharmaceuticals, Inc. | ANDA |
| 10135-823 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Marlex Pharmaceuticals, Inc. | ANDA |
| 71709-111 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Metcure Pharmaceuticals, Inc. | ANDA |
| 71709-110 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Metcure Pharmaceuticals, Inc. | ANDA |
| 71709-112 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Metcure Pharmaceuticals, Inc. | ANDA |
| 58657-726 | Metformin Hydrochloride 625 mg/1 Tablet | Method Pharmaceuticals, LLC. | ANDA |
| 58657-727 | Metformin Hydrochloride 750 mg/1 Tablet | Method Pharmaceuticals, LLC. | ANDA |
| 42571-333 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated, Extended Release | Micro Labs Limited | ANDA |
| 42571-334 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated, Extended Release | Micro Labs Limited | ANDA |
| 83301-0008 | Metformin Hydrochloride 500 mg/1 Tablet, Coated | Mullan Pharmaceutical Inc. | ANDA |
| 83301-0009 | Metformin Hydrochloride 850 mg/1 Tablet, Coated | Mullan Pharmaceutical Inc. | ANDA |
| 83301-0010 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | Mullan Pharmaceutical Inc. | ANDA |
| 0378-6002 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated, Extended Release | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6001 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated, Extended Release | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-7187 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-7185 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-7186 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-8015 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8289 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8577 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8578 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8629 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-556 | Metformin Hydrochloride 500 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-077 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-368 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-559 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-566 | Metformin Hydrochloride 1000 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-644 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-853 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-649 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 68071-3976 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3900 | Metformin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3739 | Metformin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-1419 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-5313 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-5323 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3495 | Metformin Hydrochloride 850 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3833 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3575 | Metformin Hydrochloride 850 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3518 | Metformin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3526 | Metformin Hydrochloride 1000 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3531 | Metformin Hydrochloride 850 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5306 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticcals,Inc. | ANDA |
| 72789-561 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-551 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-548 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-527 | Metformin Hydrochloride 500 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-544 | Metformin Hydrochloride 1000 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-472 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-106 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-400 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-409 | Metformin Hydrochloride 850 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-451 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-454 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-455 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-105 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68094-580 | Metformin Hydrochloride 850 mg/1 Tablet, Coated | Precision Dose, Inc. | ANDA |
| 68094-480 | Metformin Hydrochloride 1000 mg/1 Tablet, Coated | Precision Dose, Inc. | ANDA |
| 68094-688 | Metformin Hydrochloride 500 mg/1 Tablet, Coated | Precision Dose, Inc. | ANDA |
| 68094-804 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Precision Dose, Inc. | ANDA |
| 68094-904 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Precision Dose, Inc. | ANDA |
| 68788-4076 | Metformin Hydrochloride 500 mg/1 Tablet | Preferred Pharmaceuticals Inc | ANDA |
| 68788-8603 | Metformin Hydrochloride 850 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8600 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8564 | Metformin Hydrochloride 500 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8560 | Metformin Hydrochloride 1000 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8528 | Metformin Hydrochloride 850 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8652 | Metformin Hydrochloride 500 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8498 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8430 | Metformin Hydrochloride 1000 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8756 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8814 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8866 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7205 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4185 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8903 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8520 | Metformin Hydrochloride 1000 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals, Inc. | ANDA |
| 63187-779 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 63187-239 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-238 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-783 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-884 | Metformin Hydrochloride 1000 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-883 | Metformin Hydrochloride 850 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-784 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82804-309 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-686 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-622 | Metformin Hydrochloride 500 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-195 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-555 | Metformin Hydrochloride 1000 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-186 | Metformin Hydrochloride 500 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-141 | Metformin Hydrochloride 750 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-882 | Metformin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
Metformin hydrochloride recalls
- D-0328-2025 Apr 16, 2025 · Class II · Ongoing
CGMP Deviations - D-0292-2025 Apr 2, 2025 · Class II · Ongoing
Presence of Foreign Tablets/Capsules. - D-0392-2022 Feb 2, 2022 · Class II · Terminated
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. - D-0640-2021 Jun 30, 2021 · Class II · Terminated
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. - D-0372-2021 May 19, 2021 · Class II · Terminated
Presence of foreign substance: identified as activated carbon. - D-0325-2021 Apr 14, 2021 · Class III · Terminated
Failed Moisture Limits: Out of specification for water content - D-1544-2020 Sep 2, 2020 · Class II · Terminated
CGMP Deviations - D-1543-2020 Sep 2, 2020 · Class II · Terminated
CGMP Deviations - D-1382-2020 Jul 22, 2020 · Class II · Terminated
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1383-2020 Jul 22, 2020 · Class II · Terminated
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1344-2020 Jul 1, 2020 · Class II · Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1345-2020 Jul 1, 2020 · Class II · Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1347-2020 Jul 1, 2020 · Class II · Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1349-2020 Jul 1, 2020 · Class II · Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-0924-2018 Jul 25, 2018 · Class II · Terminated
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet. - D-0427-2018 Feb 28, 2018 · Class III · Terminated
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg - D-0163-2017 Dec 7, 2016 · Class II · Terminated
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP - D-1089-2014 Mar 5, 2014 · Class II · Terminated
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Frequently asked questions
What is Metformin hydrochloride used for?
Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
What are the side effects of Metformin hydrochloride?
The following adverse reactions are discussed in more detail in other sections of 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 )] Adverse reactions occurring >5% in Metformin Hydrochloride Extended-Release Tablets clinical trials: hypoglycemia,… See the full label for the complete list.
Who makes Metformin hydrochloride?
Metformin hydrochloride is listed by 52 labelers in the FDA NDC directory, including A-S Medication Solutions, ACI Healthcare USA, Inc., Advanced Rx of Tennessee, LLC, AiPing Pharmaceutical, Inc..
Has Metformin hydrochloride been recalled?
The FDA enforcement database lists 18 recalls for Metformin hydrochloride, most recently D-0328-2025 (class ii): CGMP Deviations