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 use Initial U.S. Approval: 1998
Approved
Approval ID
8345d55e-ad02-4726-a04b-1a46e3337a4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-073
Application NumberANDA202593
Product Classification
M
Marketing Category
C73584
G
Generic Name
CAPECITABINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CAPECITABINEActive
Quantity: 500 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
CAPECITABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-072
Application NumberANDA202593
Product Classification
M
Marketing Category
C73584
G
Generic Name
CAPECITABINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CAPECITABINEActive
Quantity: 150 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT