NDC 42388-013

COMETRIQ

Cabozantinib

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

Product ID42388-013_13893f7e-edcc-400b-bd4c-56bbe283ef64
NDC42388-013
Product TypeHuman Prescription Drug
Proprietary NameCOMETRIQ
Generic NameCabozantinib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2012-11-29
Marketing CategoryNDA / NDA
Application NumberNDA203756
Labeler NameExelixis, Inc.
Substance NameCABOZANTINIB S-MALATE
Active Ingredient Strength20 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42388-013-14

4 BLISTER PACK in 1 CARTON (42388-013-14) > 21 CAPSULE in 1 BLISTER PACK
Marketing Start Date2012-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42388-013-14 [42388001314]

COMETRIQ CAPSULE
Marketing CategoryNDA
Application NumberNDA203756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-29

Drug Details

Active Ingredients

IngredientStrength
CABOZANTINIB S-MALATE20 mg/1

OpenFDA Data

SPL SET ID:1a0c3bea-c87b-4d25-bb44-5f0174da6b34
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1364580
  • 1364581
  • 1363279
  • 1363312
  • 1363281
  • 1363273
  • 1363284
  • 1363408
  • 1363409
  • 1363410
  • Pharmacological Class

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

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

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

    Trademark Results [COMETRIQ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COMETRIQ
    COMETRIQ
    85331878 not registered Dead/Abandoned
    Exelixis, Inc.
    2011-05-26
    COMETRIQ
    COMETRIQ
    85331865 4354494 Live/Registered
    Exelixis, Inc.
    2011-05-26
    COMETRIQ
    COMETRIQ
    77197101 not registered Dead/Abandoned
    PowerOneData, Inc.
    2007-06-04

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