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FDA Product

Metformin Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Metformin Hydrochloride

70518-3599

Regulatory Information

70518-3599

ANDA206145

C73584

January 15, 2024

USA

These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

REMEDYREPACK INC.

829572556

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

HYPROMELLOSE 2208 (100000 MPA.S)

Code: VM7F0B23ZI

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

Code: K679OBS311

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

METFORMIN HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

Active Moieties

METFORMIN

Code: 9100L32L2N

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