On this page
glyburide-metformin hydrochloride
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Biguanide [EPC] | EPC | All 47 members |
| Biguanides [CS] | CS | All 47 members |
| Sulfonylurea Compounds [CS] | CS | All 12 members |
| Sulfonylurea [EPC] | EPC | All 12 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 079009-001 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | TABLET | GLYBURIDE; METFORMIN HYDROCHLORIDE | Prescription | AB | ||
| 079009-002 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | TABLET | GLYBURIDE; METFORMIN HYDROCHLORIDE | Prescription | AB | ||
| 079009-003 | GLYBURIDE AND METFORMIN HYDROCHLORIDE | TABLET | GLYBURIDE; METFORMIN HYDROCHLORIDE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 18 | Labeling | Approved | August 11, 2026 | Standard |
| Supplement | 11 | Labeling | Approved | June 20, 2025 | Standard |
| Supplement | 5 | Labeling | Approved | June 20, 2025 | Standard |
| Supplement | 3 | Labeling | Approved | February 18, 2015 | Standard |
| Original application | 1 | Approved | June 3, 2009 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260715). 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, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1) ]. 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 ), Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. If metformin-associated lactic acidosis is suspected, immediately discontinue glyburide and metformin hydrochloride and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions ( 5.1 ) ]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. • Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms include malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. ( 5.1 ) • Risk factors include renal impairment, concomitant use of certain drugs, age > 65 years old, radiological study with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, hepatic impairment , and mitochondrial diseases . Steps to reduce the risk of and manage metformin associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. ( 5.1 ) • If lactic acidosis is suspected, discontinue glyburide and metformin hydrochloride and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. ( 5.1 )
Recent Major Changes
openFDA Drug LabelingBoxed Warning 04/2026 Warnings and Precautions, Lactic Acidosis (5.1) 06/2026
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Glyburide and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Adult Dosage : • Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. ( 2.1 ) • For patients not treated with either glyburide (or another sulfonylurea) or metformin HCl, initiate treatment with another formulation with a dose of 1.25 mg glyburide and 250mg metformin HCl orally, once or twice daily with meals. ( 2.1 ) • For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin HCl alone, the recommended starting dose is 2.5 mg/500 mg or 5 mg/500 mg orally twice daily with meals. ( 2.1 ) • For patients previously treated with a combination therapy of glyburide (or another sulfonylurea) and metformin HCl, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin HCl already being taken. ( 2.1 ) • Increase the dose gradually on the basis of glycemic control and tolerability, up to a maximum to a maximum dose of 20 mg glyburide/2,000 mg metformin HCl daily. ( 2.1 ) Renal Impairment : Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.4 ) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.4 ) o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 ( 2.4 ) o Assess risk/benefit if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.4 ) o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.4 ) Discontinuation for Iodinated Contrast Imaging Procedures : o Glyburide and metformin hydrochloride tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.5 ) 2.1 Dosage • Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. • For patients not treated with either glyburide (or another sulfonylurea) or metformin hydrochloride (HCl), initiate treatment with another formulation of glyburide and metformin HCl at a starting dose of 1.25 mg glyburide and 250mg metformin HCl orally, once or twice daily with meals. • For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin HCl alone, the recommended starting dose of glyburide and metformin hydrochloride tablets is 2.5 mg/500 mg or 5 mg/500 mg orally twice daily with meals. • For patients previously treated with a combination therapy of glyburide (or another sulfonylurea) and metformin HCl, the starting dose of glyburide and metformin hydrochloride tablets should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin HCl already being taken. • Increase the dose gradually on the basis of glycemic control and tolerability, up to a maximum to a maximum dose of 20 mg glyburide/2,000 mg metformin HCl daily. 2.2 Patients Receiving Colesevelam • Administer glyburide and metformin hydrochloride tablets at least 4 hours prior to colesevelam for patients taking both drugs concomitantly [ see Drug Interactions ( 7 ) ]. 2.3 Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of glyburide and metformin hydrochloride tablets and periodically thereafter. • Glyburide and metformin hydrochloride tablets is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . • Initiation of glyburide and metformin hydrochloride tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. • In patients taking glyburide and metformin hydrochloride tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. • Discontinue glyburide and metformin hydrochloride tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [ see Warnings and Precautions ( 5.1 ) ]. 2.4 Discontinuation for Iodinated Contrast Imaging Procedures • Discontinue glyburide and metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Glyburide and metformin hydrochloride tablets, USP is available as: • Glyburide 1.25 mg and metformin HCl 250 mg pale yellow, oval-shaped, biconvex, film-coated tablets with "I25" debossed on one side and plain on the other side. • Glyburide 2.5 mg and metformin HCl 500 mg pale orange, oval-shaped, biconvex, film-coated tablets with "I23" debossed on one side and plain on the other side. • Glyburide 5 mg and metformin HCl 500 mg yellow, oval-shaped, biconvex, film-coated tablets with "I24" debossed on one side and plain on the other side. • Tablets: 1.25 mg glyburide and 250 mg metformin HCl ( 3 ) • Tablets: 2.5 mg glyburide and 500 mg metformin HCl ( 3 ) • Tablets: 5 mg glyburide and 500 mg metformin HCl ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Glyburide and metformin hydrochloride tablets is contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [ see Warnings and Precautions ( 5.1 ) ]. • Hypersensitivity to metformin or glyburide. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Concomitant administration of bosentan [ see Drug Interactions ( 7 ) ]. • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1 ) • Hypersensitivity to metformin or glyburide. ( 4 ) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. ( 4 ) • Concomitant administration of bosentan. ( 4 , 7 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS • Lactic Acidosis: See boxed warning. ( 5.1 ) • Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications. ( 5.2 ) • Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives. ( 5.3 ) • Hemolytic anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. ( 5.4 ) • Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. • Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities. ( Error! Hyperlink reference not valid. ) 5.1 Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels were generally >5 mcg/mL. Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of glyburide and metformin hydrochloride. In Glyburide and metformin hydrochloride 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/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 Glyburide and metformin hydrochloride and report these symptoms to their healthcare provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: • Renal Impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [ see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 ) ]: o Before initiating glyburide and metformin hydrochloride, obtain an estimated glomerular filtration rate (eGFR). o Glyburide and metformin hydrochloride is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [ see Contraindications ( ) ]. o Initiation of glyburide and metformin hydrochloride is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 . o Obtain an eGFR at least annually in all patient taking glyburide and metformin hydrochloride. 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 glyburide and metformin hydrochloride 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 glyburide and metformin hydrochloride with specific drugs may increase the risk of metformin-assoc …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions ( 5.1 ) ] • Hypoglycemia [see Warnings and Precautions ( 5.2 ) ] • Cardiovascular mortality [see Warnings and Precautions ( 5.3 ) ] • Hemolytic anemia [see Warnings and Precautions ( 5.4 ) ] • Vitamin B 12 Deficiency [see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Most common (>5%) adverse reactions to glyburide and metformin hydrochloride tablets diarrhea, headache, nausea/vomiting, abdominal pain, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In double-blind clinical studies with glyburide and metformin hydrochloride as initial therapy or as second-line therapy of 20 and 14 weeks, respectively (see section 14), a total of 642 patients received glyburide and metformin hydrochloride, 312 received metformin HCl, 324 received glyburide, and 161 received placebo. Adverse reactions are listed in Table 1. Table 1: Adverse Reactions Occurring >5% in Double-Blind Clinical Studies of Glyburide and Metformin Hydrochloride Used as Initial (20 Weeks) or Second-Line (14 Weeks) Therapy Number (%) of Patients Adverse Reaction Placebo N=161 Glyburide N=324 Metformin HCl N=312 Glyburide and Metformin Hydrochloride N=642 Diarrhea 6% 6% 21% 17% Headache 11% 11% 9% 9% Nausea/vomiting 6% 5% 12% 8% Abdominal pain 4% 3% 8% 7% Dizziness 4% 6% 4% 6% Hypoglycemia The incidence of reported symptoms of hypoglycemia (such as dizziness, shakiness, sweating, and hunger), in the initial therapy study of glyburide and metformin hydrochloride are summarized in Table 2. For patients with a baseline HbA1c between 8% and 11% treated with glyburide and metformin hydrochloride 2.5 mg/500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30% to 35%. As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with glyburide and metformin hydrochloride experienced hypoglycemic symptoms. Gastrointestinal Reactions The incidence of gastrointestinal (GI) side effects (diarrhea, nausea/vomiting, and abdominal pain) in the glyburide and metformin hydrochloride initial therapy study are summarized in Table 2. Across all glyburide and metformin hydrochloride studies, GI symptoms were the most common adverse events with glyburide and metformin hydrochloride and were more frequent at higher dose levels. In controlled studies, <2% of patients discontinued glyburide and metformin hydrochloride therapy due to GI adverse events. Table 2: Hypoglycemia or Gastrointestinal Adverse Reactions in a Placebo and Active-Controlled Study of Glyburide and Metformin Hydrochloride as Initial Therapy (20 Weeks) Variable Placebo N=161 Glyburide Tablets N=160 Metformin HCl Tablets N=159 Glyburide and Metformin Hydrochloride 1.25 mg/250 mg Tablets N=158 Glyburide and Metformin Hydrochloride 2.5 mg/500 mg Tablets N=162 Number (%) of patients with symptoms of hypoglycemia 3% 21% 3% 11% 38% Number (%) of patients with gastrointestinal adverse events 24% 24% 43% 32% 38% Dermatologic Reactions Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in 1.5% of glyburide-treated patients. These may be transient and may disappear despite continued use. 6.2 Postmarketing Adverse Reactions The following adverse reactions have been identified during post-approval use of glyburide and metformin hydrochloride. Because these reactions are reported voluntarily from a popula …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Table 3 presents clinically significant drug interactions with glyburide and metformin hydrochloride. Table 3: Clinically Significant Drug Interactions with Glyburide and Metformin Hydrochloride 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 glyburide and metformin hydrochloride may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide and dichlorphenamide. Drugs that Reduce Metformin 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 glyburide and metformin hydrochloride. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of metformin on lactate metabolism. Intervention: Warn patients against excessive alcohol intake while receiving glyburide and metformin hydrochloride. Drugs that potentiate the hypoglycemic action of glyburide and metformin hydrochloride Clinical Impact: Certain drugs may potentiate the hypoglycemic action of sulfonylureas, one of the components of glyburide and metformin hydrochloride. Intervention: Closely observe patient for hypoglycemia during co-administration and for loss of glycemic control when withdrawing these agents. Examples: Nonsteroidal anti-inflammatory agents and other highly protein-boind drugs, salicylcates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, beta-adrenergic blocking agents; potentially with ciprofloxacin, micronazole. Bosentan Clinical Impact: Increased risk of liver enzyme elevations was observed. Intervention: Concomitant administration is contraindicated. Colesevalam Clinical Impact: Concomitant administration may led to reduced glyburide absorption (AUC and Cmax: -32% and -47%, respectively). Intervention: Glyburide and metformin hydrochloride should be administered at least 4 hours prior to colesevelam. Drugs Reducing 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 glyburide and metformin hydrochloride observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving glyburide and metformin hydrochloride, 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 ) • The hypoglycemic action of glyburide and metformin hydrochloride tablets may be potentiated by certain drugs. ( 7 ) • Concomitant administration of colesevalam may led to reduced glyburide absorption. ( 7 )
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS • Pregnancy: Glyburide and metformin hydrochloride tablets should be discontinued at least two weeks before expected delivery. ( 8.1 ) • 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 Available data from a small number of published studies and postmarketing experience with glyburide use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glyburide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glyburide and metformin hydrochloride should be discontinued at least two weeks before expected delivery [see Clinical Considerations ]. Limited data with metformin 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 evidence of harm to the fetus was observed when doses up to 500 times the maximum recommended human dose of 20 mg of glyburide, based on body surface area, were administered to rats and rabbits in reproduction studies. 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 6- 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 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, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Fetal/Neonatal Adverse Reactions Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. Prolonged severe hypoglycemia, lasting 4 to 10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly. Dose adjustments during pregnancy and the postpartum period Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glyburide and metformin hydrochloride should be discontinued at least two weeks before expected delivery [see Fetal/Neonatal Adverse Reactions ]. 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 de …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Glyburide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin. Metformin is an antihyperglycemic agent 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 daylong plasma insulin response may decrease.
Description
openFDA Drug Labeling11 DESCRIPTION Glyburide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetis, glyburide USP and metformin hydrochloride USP. Glyburide, USP is an oral antihyperglycemia sulfonylurea class. The chemical name for glyburide USP is 1-[[ p -[2-(5-chloro- o -anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with a molecular formula of C 23 H 28 ClN 3 O 5 S and a molecular weight of 494.01. Micronised glyburide is used in glyburide and metformin hydrochloride tablets, USP. The structural formula is represented below. Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N -dimethylimidodicarbonimidic diamide monohydrochloride) Is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C 4 H 12 CIN 5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown: Glyburide and metformin hydrochloride tablets, USP are available for oral administration in tablets containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Povidone, Colloidal Silicon Dioxide, Magnesium Stearate. The tablets are film coated, which provides color differentiation. Additionally 1.25 mg/250 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol and Iron Oxide Yellow. The 2.5 mg/500 mg tablet contains Opadry Pink which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and Iron Oxide Red. The 5 mg/500 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and D & C Yellow #10 Aluminium Lake. Meets USP Dissolution Test 1 Chem structure 1 Chem structure 2
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Glyburide Overdosage of sulfonylureas, including glyburide tablets, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated with oral glucose. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment are medical emergencies requiring immediate treatment. The patient should be treated with glucagon or intravenous glucose. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glyburide from plasma may be prolonged in persons with liver disease. Because of the extensive protein binding of glyburide, dialysis is unlikely to be of benefit. Metformin Overdose of metformin has occurred, including ingestion of amounts greater than 50 g. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions ( 5.1 ) ]. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Glyburide-metformin hydrochloride tablet 5mg/500 mg: color yellow, oval (biconvex), size 15mm and imprint code 124. NDC 71335-2508-1: 30 Tablets in a BOTTLE NDC 71335-2508-3: 60 Tablets in a BOTTLE NDC 71335-2508-4: 90 Tablets in a BOTTLE NDC 71335-2508-5: 120 Tablets in a BOTTLE NDC 71335-2508-6: 100 Tablets in a BOTTLE NDC 71335-2508-7: 180 Tablets in a BOTTLE NDC 71335-2508-8: 25 Tablets in a BOTTLE Store at temperatures up to 25°C (77°F). [See USP Controlled Room Temperature]. Dispense in light-resistant containers. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
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 |
|---|---|---|---|---|
| 50090-7514-0 | 50090-7514 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7514-0) | March 3, 2025 |
| 50090-7514-2 | 50090-7514 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7514-2) | March 3, 2025 |
| 50090-7514-3 | 50090-7514 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7514-3) | March 3, 2025 |
| 50090-7514-4 | 50090-7514 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-7514-4) | March 3, 2025 |
| 50090-7814-0 | 50090-7814 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7814-0) | December 9, 2025 |
| 50090-7814-2 | 50090-7814 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-7814-2) | December 9, 2025 |
| 71335-2508-1 | 71335-2508 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2508-1) | October 21, 2024 |
| 71335-2508-3 | 71335-2508 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2508-3) | October 21, 2024 |
| 71335-2508-4 | 71335-2508 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2508-4) | October 21, 2024 |
| 71335-2508-5 | 71335-2508 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2508-5) | October 21, 2024 |
| 71335-2508-6 | 71335-2508 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2508-6) | October 21, 2024 |
| 71335-2508-7 | 71335-2508 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2508-7) | October 21, 2024 |
| 71335-2508-8 | 71335-2508 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-2508-8) | October 21, 2024 |
| 71335-2694-1 | 71335-2694 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2694-1) | September 24, 2025 |
| 71335-2694-2 | 71335-2694 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2694-2) | September 24, 2025 |
| 71335-2694-3 | 71335-2694 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2694-3) | September 24, 2025 |
| 71335-2694-4 | 71335-2694 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2694-4) | September 24, 2025 |
| 71335-2694-5 | 71335-2694 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2694-5) | September 24, 2025 |
| 23155-233-01 | 23155-233 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-233-01) | May 1, 2024 |
| 23155-233-05 | 23155-233 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-233-05) | May 1, 2024 |
| 23155-233-10 | 23155-233 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-233-10) | May 1, 2024 |
| 23155-234-01 | 23155-234 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-234-01) | May 1, 2024 |
| 23155-234-05 | 23155-234 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-234-05) | May 1, 2024 |
| 23155-234-10 | 23155-234 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-234-10) | May 1, 2024 |
| 23155-235-01 | 23155-235 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-235-01) | May 1, 2024 |
| 23155-235-05 | 23155-235 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-235-05) | May 1, 2024 |
| 23155-235-10 | 23155-235 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-235-10) | May 1, 2024 |
| 68071-3950-3 | 68071-3950 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68071-3950-3) | January 15, 2026 |
| 68788-8791-1 | 68788-8791 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8791-1) | December 17, 2024 |
| 68788-8791-3 | 68788-8791 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8791-3) | December 17, 2024 |
| 68788-8791-6 | 68788-8791 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8791-6) | December 17, 2024 |
| 68788-8791-8 | 68788-8791 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-8791-8) | December 17, 2024 |
| 68788-8791-9 | 68788-8791 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8791-9) | December 17, 2024 |
| 50090-7514 | 50090-7514 | A-S Medication Solutions | — | May 1, 2024 |
| 50090-7814 | 50090-7814 | A-S Medication Solutions | — | May 1, 2024 |
| 71335-2508 | 71335-2508 | Bryant Ranch Prepack | — | May 1, 2024 |
| 71335-2694 | 71335-2694 | Bryant Ranch Prepack | — | May 1, 2024 |
| 23155-233 | 23155-233 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | May 1, 2024 |
| 23155-234 | 23155-234 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | May 1, 2024 |
| 23155-235 | 23155-235 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | May 1, 2024 |
| 68071-3950 | 68071-3950 | NuCare Pharmaceuticals, Inc. | — | May 1, 2024 |
| 68788-8791 | 68788-8791 | Preferred Pharmaceuticals Inc. | — | December 17, 2024 |
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 · 11 sections on this page.