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FDA Drug information

METFORMIN HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 27 Apr 2024

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

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