MedPath
FDA Product

Metformin Hydrochloride

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

Basic Information

Metformin Hydrochloride

67877-217

Regulatory Information

67877-217

ANDA091184

C73584

November 24, 2021

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

23

Company Information

141250469

Active Ingredients

METFORMIN HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

METFORMIN

Code: 9100L32L2N

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