Xeloda
These highlights do not include all the information needed to use XELODA safely and effectively. See full prescribing information for XELODA. XELODA (capecitabine) Tablets, Film Coated for Oral use Initial U.S. Approval: 1998
Approved
Approval ID
6b76b5bb-1d69-43f9-99c6-f39a0b6d8a26
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
capecitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5260
Application NumberNDA020896
Product Classification
M
Marketing Category
C73594
G
Generic Name
capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2012
FDA Product Classification
INGREDIENTS (10)
waterInactive
Code: 059QF0KO0R
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
capecitabineActive
Quantity: 500 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
Hypromellose 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
capecitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4143
Application NumberNDA020896
Product Classification
M
Marketing Category
C73594
G
Generic Name
capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2012
FDA Product Classification
INGREDIENTS (10)
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
hypromellose 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
capecitabineActive
Quantity: 150 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT