MedPath
FDA Product

Capecitabine 150mg

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

Basic Information

Capecitabine 150mg

72485-204

Regulatory Information

72485-204

ANDA207456

C73584

December 23, 2020

USA

These highlights do not include all the information needed to use CAPECITABINE TABLETS safely and effectively. See full prescribing information for CAPECITABINE TABLETS. CAPECITABINE tablets, for oral useInitial U.S. Approval: 1998

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

098405973

Active Ingredients

CAPECITABINE

Quantity: 150 mg in 1 1

Code: 6804DJ8Z9U

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

CAPECITABINE

Code: 6804DJ8Z9U

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