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FDA Approval

Metformin Hydrochloride

CompanyRedPharm Drug, Inc. (DUNS: 828374897)

Effective Date

January 14, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(500 mg in 1 1)

Manufacturing Establishments (1)

RedPharm Drug, Inc.

Labeler

RedPharm Drug, Inc.

DUNS Number

828374897

Products (1)

Metformin Hydrochloride

NDC Product Code

67296-1701

Application Number

ANDA078321

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 14, 2021

Ingredients

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive

Code: K679OBS311Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

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