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FDA Approval

METFORMIN HYDROCHLORIDE

CompanyRedPharm Drug, Inc. (DUNS: 828374897)

Effective Date

January 21, 2022

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

67296-1527

Application Number

ANDA077336

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 21, 2022

Ingredients

MetforminActive

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

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

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