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- METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500 mg/1 Zydus Lifesciences Limited
METFORMIN HYDROCHLORIDE
- 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
- 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
- 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.
- 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
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 7.5 mg/1 Merck Sharp & Dohme LLC
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 2.5 mg/1 Merck Sharp & Dohme LLC
- 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.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 REMEDYREPACK INC.
- Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 A-S Medication Solutions
- Glyburide and Metformin Hydrochloride GLYBURIDE 5 mg/1 PD-Rx Pharmaceuticals, Inc.
- INVOKAMET CANAGLIFLOZIN 50 mg/1 Janssen Pharmaceuticals, Inc.
- Pioglitazone and metformin METFORMIN HYDROCHLORIDE 500 mg/1 Sandoz 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.
- Jentadueto LINAGLIPTIN 2.5 mg/1 Boehringer Ingelheim Pharmaceuticals, 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
- SEGLUROMET ERTUGLIFLOZIN PIDOLATE 7.5 mg/1 Merck Sharp & Dohme LLC
- INVOKAMET CANAGLIFLOZIN 150 mg/1 Janssen Pharmaceuticals, Inc.
- 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
- JANUMET METFORMIN HYDROCHLORIDE 500 mg/1 Merck Sharp & Dohme LLC
- METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500 mg/1 Zydus Lifesciences Limited
- 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.
- 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
- Pioglitazone Hydrochloride and Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 Rising Health, LLC
- Pioglitazone Hydrochloride and Metformin Hydrochloride METFORMIN HYDROCHLORIDE 500 mg/1 AvKARE
Summary of product characteristics
Effective Time
20221031
Version
11
Spl Product Data Elements
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE ROUND 70;Z METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE OVAL 69;Z METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE OVAL Z;71 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE ROUND 70;Z METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE OVAL 69;Z METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE OVAL Z;71
Application Number
ANDA203686
Brand Name
METFORMIN HYDROCHLORIDE
Generic Name
METFORMIN HYDROCHLORIDE
Product Ndc
65841-809
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-028-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 mg Rx only 100 tablets NDC 65841-809-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 mg Rx only 100 tablets NDC 65841-029-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 850 mg Rx only 100 tablets NDC 65841-810-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 850 mg Rx only 100 tablets NDC 65841-030-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets NDC 65841-811-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets Image Image Image Image Image Image
Drug section
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