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FDA Product

METFORMIN HYDROCHLORIDE

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

Basic Information

METFORMIN HYDROCHLORIDE

71093-132

Regulatory Information

71093-132

ANDA203769

C73584

December 26, 2019

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

6

Company Information

080430318

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

METFORMIN HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

STARCH, PREGELATINIZED CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

DEXTROSE

Code: IY9XDZ35W2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ACACIA

Code: 5C5403N26O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

METFORMIN

Code: 9100L32L2N

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