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FDA Drug information

METFORMIN HCL

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20191230

Version

5

Spl Product Data Elements

METFORMIN HCL METFORMIN HCL POVIDONE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE METFORMIN HYDROCHLORIDE METFORMIN WHITE TO OFF-WHITE 132 METFORMIN HCL METFORMIN HCL POVIDONE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE METFORMIN HYDROCHLORIDE METFORMIN WHITE TO OFF-WHITE 131 METFORMIN HCL METFORMIN HCL POVIDONE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE METFORMIN HYDROCHLORIDE METFORMIN WHITE TO OFF-WHITE 134

Application Number

ANDA090888

Brand Name

METFORMIN HCL

Generic Name

METFORMIN HCL

Product Ndc

49483-620

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

100 ct 620R 1000 MG 100CT 620R

How Supplied

HOW SUPPLIED METFORMIN HYDROCHLORIDE TABLETS, USP 500 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "134" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

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