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, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
e702d84d-7162-4751-bf37-d724cc7e45a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
H2-Pharma, LLC
DUNS: 028473634
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 Code61269-470
Application NumberNDA020896
Product Classification
M
Marketing Category
C73594
G
Generic Name
capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2023
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 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CAPECITABINEActive
Quantity: 150 mg in 1 1
Code: 6804DJ8Z9U
Classification: ACTIB
capecitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-475
Application NumberNDA020896
Product Classification
M
Marketing Category
C73594
G
Generic Name
capecitabine
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2023
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
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
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT