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FDA Approval

Metformin Hydrochloride

CompanyQuality Care Products, LLC (DUNS: 831276758)

Effective Date

November 17, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(500 mg in 1 1)

Manufacturing Establishments (1)

Quality Care Products, LLC

Labeler

Quality Care Products, LLC

DUNS Number

831276758

Products (1)

Metformin Hydrochloride

NDC Product Code

55700-734

Application Number

ANDA078321

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 26, 2020

Ingredients

Copovidone K25-31Inactive

Code: D9C330MD8BClass: IACT

MetforminActive

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

carboxymethylcellulose sodium, unspecified formInactive

Code: K679OBS311Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

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