Xeloda
XELODA (capecitabine) TABLETS
Approved
Approval ID
a732b303-9bbd-42ba-a7c5-61c21629ba93
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 20, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
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 Code53808-0411
Application NumberNDA020896
Product Classification
M
Marketing Category
C73594
G
Generic Name
capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification
INGREDIENTS (12)
CAPECITABINEActive
Quantity: 500 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2208 (15000 CPS)Inactive
Code: Z78RG6M2N2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT