NDC 42388-025

CABOMETYX

Cabozantinib

CABOMETYX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Exelixis, Inc.. The primary component is Cabozantinib S-malate.

Product ID42388-025_06f8c3b3-d011-4ee6-9186-ee07478ac60e
NDC42388-025
Product TypeHuman Prescription Drug
Proprietary NameCABOMETYX
Generic NameCabozantinib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-04-25
Marketing CategoryNDA / NDA
Application NumberNDA208692
Labeler NameExelixis, Inc.
Substance NameCABOZANTINIB S-MALATE
Active Ingredient Strength40 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42388-025-26

30 TABLET in 1 BOTTLE (42388-025-26)
Marketing Start Date2016-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42388-025-26 [42388002526]

CABOMETYX TABLET
Marketing CategoryNDA
Application NumberNDA208692
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-25

NDC 42388-025-37 [42388002537]

CABOMETYX TABLET
Marketing CategoryNDA
Application NumberNDA208692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-27

Drug Details

Active Ingredients

IngredientStrength
CABOZANTINIB S-MALATE40 mg/1

OpenFDA Data

SPL SET ID:3850cce2-6137-42e5-a792-d318c4a4b3b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790161
  • 1790167
  • 1790169
  • 1790175
  • 1790173
  • 1790171
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]

    NDC Crossover Matching brand name "CABOMETYX" or generic name "Cabozantinib"

    NDCBrand NameGeneric Name
    42388-023CABOMETYXcabozantinib
    42388-024CABOMETYXcabozantinib
    42388-025CABOMETYXcabozantinib
    42388-011COMETRIQcabozantinib
    42388-012COMETRIQcabozantinib
    42388-013COMETRIQcabozantinib

    Trademark Results [CABOMETYX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CABOMETYX
    CABOMETYX
    86927889 not registered Live/Pending
    Exelixis, Inc.
    2016-03-03
    CABOMETYX
    CABOMETYX
    86621339 5105828 Live/Registered
    Exelixis, Inc.
    2015-05-06
    CABOMETYX
    CABOMETYX
    86471554 not registered Dead/Abandoned
    Exelixis, Inc.
    2014-12-04
    CABOMETYX
    CABOMETYX
    85331905 not registered Dead/Abandoned
    Exelixis, Inc.
    2011-05-26
    CABOMETYX
    CABOMETYX
    85331904 not registered Dead/Abandoned
    Exelixis, Inc.
    2011-05-26

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