COMETRIQ
These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ (cabozantinib) capsules, for oral useInitial U.S. Approval: 2012
Approved
Approval ID
1a0c3bea-c87b-4d25-bb44-5f0174da6b34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 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 Code42388-013
Application NumberNDA203756
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabozantinib
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2016
FDA Product Classification
INGREDIENTS (14)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
cabozantinib s-malateActive
Quantity: 20 mg in 1 1
Code: DR7ST46X58
Classification: ACTIM
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
cabozantinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42388-012
Application NumberNDA203756
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabozantinib
Product Specifications
Effective DateMay 23, 2016
FDA Product Classification
cabozantinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42388-011
Application NumberNDA203756
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabozantinib
Product Specifications
Effective DateMay 23, 2016
FDA Product Classification