MedPath
FDA Product

METFORMIN HYDROCHLORIDE

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

Basic Information

METFORMIN HYDROCHLORIDE

70518-3735

Regulatory Information

70518-3735

ANDA203769

C73584

March 28, 2024

USA

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

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

REMEDYREPACK INC.

829572556

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

DEXTROSE, UNSPECIFIED FORM

Code: IY9XDZ35W2

Class Code: IACT

ACACIA

Code: 5C5403N26O

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

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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