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 ID: 42388-013_13893f7e-edcc-400b-bd4c-56bbe283ef64
• NDC: 42388-013
• Product Type: Human Prescription Drug
• Proprietary Name: COMETRIQ
• Generic Name: Cabozantinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2012-11-29
• Marketing Category: NDA / NDA
• Application Number: NDA203756
• Labeler Name: Exelixis, Inc.
• Substance Name: CABOZANTINIB S-MALATE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42388-013-14

4 BLISTER PACK in 1 CARTON (42388-013-14) > 21 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2012-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42388-013-14 [42388001314]

COMETRIQ CAPSULE

• Marketing Category: NDA
• Application Number: NDA203756
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-11-29

Drug Details

Active Ingredients

Ingredient	Strength
CABOZANTINIB S-MALATE	20 mg/1

OpenFDA Data

• SPL SET ID: 1a0c3bea-c87b-4d25-bb44-5f0174da6b34
• Manufacturer:
  • Exelixis, Inc.
• UNII:
  • DR7ST46X58
• 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"

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