NDC 42388-023

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 ID: 42388-023_06f8c3b3-d011-4ee6-9186-ee07478ac60e
• NDC: 42388-023
• Product Type: Human Prescription Drug
• Proprietary Name: CABOMETYX
• Generic Name: Cabozantinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-25
• Marketing Category: NDA / NDA
• Application Number: NDA208692
• Labeler Name: Exelixis, Inc.
• Substance Name: CABOZANTINIB S-MALATE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 42388-023-26

30 TABLET in 1 BOTTLE (42388-023-26)

• Marketing Start Date: 2016-04-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42388-023-26 [42388002326]

CABOMETYX TABLET

• Marketing Category: NDA
• Application Number: NDA208692
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-25

NDC 42388-023-37 [42388002337]

CABOMETYX TABLET

• Marketing Category: NDA
• Application Number: NDA208692
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-03

NDC 42388-023-36 [42388002336]

CABOMETYX TABLET

• Marketing Category: NDA
• Application Number: NDA208692
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-16

Drug Details

Active Ingredients

Ingredient	Strength
CABOZANTINIB S-MALATE	60 mg/1

OpenFDA Data

• SPL SET ID: 3850cce2-6137-42e5-a792-d318c4a4b3b5
• Manufacturer:
  • Exelixis, Inc.
• UNII:
  • DR7ST46X58
• 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"

NDC	Brand Name	Generic Name
42388-023	CABOMETYX	cabozantinib
42388-024	CABOMETYX	cabozantinib
42388-025	CABOMETYX	cabozantinib
42388-011	COMETRIQ	cabozantinib
42388-012	COMETRIQ	cabozantinib
42388-013	COMETRIQ	cabozantinib