NDC 63539-197

Vizimpro

Dacomitinib

Vizimpro 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 Dacomitinib.

• Product ID: 63539-197_5d0a5fdf-38fd-4b4b-aecd-277d389345ae
• NDC: 63539-197
• Product Type: Human Prescription Drug
• Proprietary Name: Vizimpro
• Generic Name: Dacomitinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA211288
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: DACOMITINIB
• Active Ingredient Strength: 15 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63539-197-90

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63539-197-90)

• Marketing Start Date: 2019-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63539-197-90 [63539019790]

Vizimpro TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211288
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-01

Drug Details

Active Ingredients

Ingredient	Strength
DACOMITINIB	15 mg/1

OpenFDA Data

• SPL SET ID: 90da33c1-5689-4b4d-a2b5-377e1057a843
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • 5092U85G58
• RxNorm Concept Unique ID - RxCUI:
  • 2058915
  • 2058922

NDC Crossover Matching brand name "Vizimpro" or generic name "Dacomitinib"

NDC	Brand Name	Generic Name
0069-0197	Vizimpro	dacomitinib
0069-1198	Vizimpro	dacomitinib
0069-2299	Vizimpro	dacomitinib
63539-197	Vizimpro	dacomitinib