NDC 0069-0145

INLYTA

Axitinib

INLYTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Axitinib.

• Product ID: 0069-0145_50eb7178-6a41-45da-85d0-70c16e5b7a03
• NDC: 0069-0145
• 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: Pfizer Laboratories Div Pfizer Inc
• Substance Name: AXITINIB
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0069-0145-01

180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01)

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

NDC SPL Data Element Entries

NDC 0069-0145-01 [00069014501]

INLYTA TABLET, FILM COATED

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

Drug Details

Active Ingredients

Ingredient	Strength
AXITINIB	1 mg/1

OpenFDA Data

• SPL SET ID: 84137882-e000-47da-bd5b-fa76ab3c76f9
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • C9LVQ0YUXG
• RxNorm Concept Unique ID - RxCUI:
  • 1243012
  • 1243004
  • 1243010
  • 1243014
• UPC Code:
  • 0300690151113
  • 0300690145013

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