Capecitabine
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
Approved
Approval ID
e3b1a2b5-f1ce-45ea-afd8-68aac53665fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-238
Application NumberANDA204668
Product Classification
M
Marketing Category
C73584
G
Generic Name
Capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CAPECITABINEActive
Quantity: 150 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Capecitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-239
Application NumberANDA204668
Product Classification
M
Marketing Category
C73584
G
Generic Name
Capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (12)
CAPECITABINEActive
Quantity: 500 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT