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FDA Product

Glyburide and Metformin

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

Basic Information

Glyburide and Metformin

54868-5148

Regulatory Information

54868-5148

ANDA076345

C73584

December 20, 2011

USA

GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USPRx only571057115712

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

194123980

Active Ingredients

COPOVIDONE

Code: D9C330MD8B

Class Code: IACT

Glyburide

Quantity: 2.5 mg in 1 1

Code: SX6K58TVWC

Class Code: ACTIB

Metformin Hydrochloride

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

Active Moieties

Glyburide

Code: SX6K58TVWC

METFORMIN

Code: 9100L32L2N

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