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- METFORMIN HCL METFORMIN HYDROCHLORIDE 500 mg/1 TIME CAP LABORATORIES, INC
METFORMIN HCL
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Metcure Pharmaceuticals, Inc.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 A-S Medication Solutions
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 REMEDYREPACK INC.
- Glipizide and Metformin Hydrochloride GLIPIZIDE 2.5 mg/1 A-S Medication Solutions
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 Zydus Pharmaceuticals USA Inc.
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 2.5 mg/1 Merck Sharp & Dohme LLC
- Glipizide and metformin hcl GLIPIZIDE 2.5 mg/1 Chartwell RX, LLC
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 Teva Pharmaceuticals USA, Inc.
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 Zydus Lifesciences Limited
- Glipizide and Metformin Hydrochloride GLIPIZIDE 2.5 mg/1 Zydus Pharmaceuticals USA Inc.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Aurobindo Pharma Limited
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Proficient Rx LP
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 A-S Medication Solutions
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 Rising Health, LLC
- Glipizide and metformin hcl GLIPIZIDE 5 mg/1 Chartwell RX, LLC
- Glipizide and Metformin Hydrochloride GLIPIZIDE 2.5 mg/1 Zydus Lifesciences Limited
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Proficient Rx LP
- Metformin hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Macleods Pharmaceuticals Limited
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 REMEDYREPACK INC.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Bryant Ranch Prepack
- METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500 mg/1 Zydus Pharmaceuticals USA Inc.
- Pioglitazone Hydrochloride and Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Aurobindo Pharma Limited
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 REMEDYREPACK INC.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Alogliptin and metformin hydrochloride ALOGLIPTIN BENZOATE 12.5 mg/1 Padagis Israel Pharmaceuticals Ltd
- KAZANO ALOGLIPTIN BENZOATE 12.5 mg/1 Takeda Pharmaceuticals America, Inc.
- Glyburide and Metformin Hydrochloride GLYBURIDE 2.5 mg/1 Aurobindo Pharma Limited
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 Preferred Pharmaceuticals Inc.
- Glyburide and Metformin Hydrochloride GLYBURIDE 2.5 mg/1 A-S Medication Solutions
- Glipizide and metformin hcl GLIPIZIDE 5 mg/1 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 7.5 mg/1 Merck Sharp & Dohme LLC
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 2.5 mg/1 Merck Sharp & Dohme LLC
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 PD-Rx Pharmaceuticals, Inc.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Preferred Pharmaceuticals Inc.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 NuCare Pharmaceuticals,Inc.
- INVOKAMET CANAGLIFLOZIN 50 mg/1 Janssen Pharmaceuticals, Inc.
- Jentadueto LINAGLIPTIN 2.5 mg/1 Boehringer Ingelheim Pharmaceuticals, Inc.
- Pioglitazone and metformin METFORMIN HYDROCHLORIDE 500 mg/1 Sandoz Inc
- Glyburide and Metformin Hydrochloride GLYBURIDE 2.5 mg/1 A-S Medication Solutions
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 Northwind Pharmaceuticals, LLC
- Glyburide and Metformin Hydrochloride GLYBURIDE 2.5 mg/1 Preferred Pharmaceuticals Inc.
- Glipizide and metformin hcl GLIPIZIDE 2.5 mg/1 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 REMEDYREPACK INC.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 MARKSANS PHARMA LIMITED
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Ascend Laboratories, LLC
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- JANUMET METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 Bryant Ranch Prepack
- Glipizide and Metformin Hydrochloride GLIPIZIDE 2.5 mg/1 Teva Pharmaceuticals USA, Inc.
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 A-S Medication Solutions
- METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500 mg/1 Zydus Lifesciences Limited
- JANUMET METFORMIN HYDROCHLORIDE 500 mg/1 Merck Sharp & Dohme LLC
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 7.5 mg/1 Merck Sharp & Dohme LLC
- INVOKAMET CANAGLIFLOZIN 150 mg/1 Janssen Pharmaceuticals, Inc.
- Pioglitazone Hydrochloride and Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Rising Health, LLC
- Pioglitazone Hydrochloride and Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 AvKARE
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Mylan Pharmaceuticals Inc.
- METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500 mg/1 Zydus Lifesciences Limited
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Epic Pharma, LLC
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Proficient Rx LP
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Laurus Labs Limited
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 American Health Packaging
- METFORMIN HCL METFORMIN HYDROCHLORIDE 500 mg/1 TIME CAP LABORATORIES, INC
- JANUMET METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 Bryant Ranch Prepack
- Glipizide and Metformin HCl GLIPIZIDE 5 mg/1 Proficient Rx LP
- Glipizide and metformin hcl GLIPIZIDE 5 mg/1 REMEDYREPACK INC.
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 A-S Medication Solutions
- Glipizide and Metformin Hydrochloride GLIPIZIDE 5 mg/1 REMEDYREPACK INC.
Summary of product characteristics
Effective Time
20191230
Version
5
Spl Product Data Elements
METFORMIN HCL METFORMIN HCL POVIDONE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE METFORMIN HYDROCHLORIDE METFORMIN WHITE TO OFF-WHITE 132 METFORMIN HCL METFORMIN HCL POVIDONE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE METFORMIN HYDROCHLORIDE METFORMIN WHITE TO OFF-WHITE 131 METFORMIN HCL METFORMIN HCL POVIDONE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE METFORMIN HYDROCHLORIDE METFORMIN WHITE TO OFF-WHITE 134
Application Number
ANDA090888
Brand Name
METFORMIN HCL
Generic Name
METFORMIN HCL
Product Ndc
49483-622
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
100 ct 620R 1000 MG 100CT 620R
How Supplied
HOW SUPPLIED METFORMIN HYDROCHLORIDE TABLETS, USP 500 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "134" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.
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