NDC 0069-0197

Vizimpro

Dacomitinib

Vizimpro 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 Dacomitinib.

• Product ID: 0069-0197_470f74a3-f9ef-4a24-9bcd-aa54a3538ea9
• NDC: 0069-0197
• Product Type: Human Prescription Drug
• Proprietary Name: Vizimpro
• Generic Name: Dacomitinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-04
• Marketing Category: NDA / NDA
• Application Number: NDA211288
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: DACOMITINIB
• Active Ingredient Strength: 15 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0069-0197-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)

• Marketing Start Date: 2018-10-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0197-30 [00069019730]

Vizimpro TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211288
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-04

Drug Details

Active Ingredients

Ingredient	Strength
DACOMITINIB	15 mg/1

OpenFDA Data

• SPL SET ID: 4ab27d2f-e385-4e9c-b324-fa69c10b855a
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 5092U85G58
• RxNorm Concept Unique ID - RxCUI:
  • 2058926
  • 2058924
  • 2058930
  • 2058922
  • 2058932
  • 2058915
• UPC Code:
  • 0300692299301
  • 0300690197302
  • 0300691198308

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