CAPECITABINE

Basic Information

Product Name

CAPECITABINE

FDA Product Code

16714-467

Regulatory Information

NDC Product Code

16714-467

Application Number

ANDA202593

Marketing Category

C73584

Effective Date

January 27, 2022

Territorial Authority

USA

FDA Title

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 use Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

CAPECITABINE

Quantity: 150 mg in 1 1

Code: 6804DJ8Z9U

Class Code: ACTIB

Active Moieties

Code: 6804DJ8Z9U

CAPECITABINE

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSCARMELLOSE SODIUM

HYPROMELLOSE 2910 (5 MPA.S)

MAGNESIUM STEARATE

FERRIC OXIDE RED

ANHYDROUS LACTOSE

HYPROMELLOSE 2910 (6 MPA.S)

CELLULOSE, MICROCRYSTALLINE

TALC

TITANIUM DIOXIDE

FERRIC OXIDE YELLOW

Active Moieties

CAPECITABINE