NDC 63539-044

INLYTA

Axitinib

INLYTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Axitinib.

• Product ID: 63539-044_009196c1-a9cb-4db0-a4cf-aeffca114312
• NDC: 63539-044
• Product Type: Human Prescription Drug
• Proprietary Name: INLYTA
• Generic Name: Axitinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-01-27
• Marketing Category: NDA / NDA
• Application Number: NDA202324
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: AXITINIB
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 63539-044-01

60 TABLET, FILM COATED in 1 BOTTLE (63539-044-01)

• Marketing Start Date: 2012-01-27
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 63539-044-02 [63539004402]

INLYTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202324
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-01-27

NDC 63539-044-01 [63539004401]

INLYTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202324
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-01-27

Drug Details

Active Ingredients

Ingredient	Strength
AXITINIB	5 mg/1

OpenFDA Data

• SPL SET ID: 8a903e31-936e-4ed7-8a59-59f32374f338
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • C9LVQ0YUXG
• RxNorm Concept Unique ID - RxCUI:
  • 1243012
  • 1243004
  • 1243010
  • 1243014

Pharmacological Class

• Kinase Inhibitor [EPC]
• Receptor Tyrosine Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "INLYTA" or generic name "Axitinib"

NDC	Brand Name	Generic Name
0069-0145	INLYTA	axitinib
0069-0151	INLYTA	axitinib
63539-026	INLYTA	axitinib
63539-044	INLYTA	axitinib