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FDA Product

Metformin Hydrochloride

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

Basic Information

Metformin Hydrochloride

25000-101

Regulatory Information

25000-101

ANDA090295

C73584

June 23, 2022

USA

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

Human Prescription Drug Label

12

Company Information

925822975

Active Ingredients

METFORMIN HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSE 2208 (100 MPA.S)

Code: B1QE5P712K

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

METFORMIN

Code: 9100L32L2N

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