CABOMETYX
These highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX.CABOMETYX (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
3850cce2-6137-42e5-a792-d318c4a4b3b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2023
Manufacturers
FDA
Exelixis, Inc.
DUNS: 785991949
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cabozantinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42388-023
Application NumberNDA208692
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabozantinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (11)
cabozantinib s-malateActive
Quantity: 60 mg in 1 1
Code: DR7ST46X58
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
cabozantinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42388-024
Application NumberNDA208692
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabozantinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
cabozantinib s-malateActive
Quantity: 20 mg in 1 1
Code: DR7ST46X58
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
cabozantinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42388-025
Application NumberNDA208692
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabozantinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (11)
cabozantinib s-malateActive
Quantity: 40 mg in 1 1
Code: DR7ST46X58
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT