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 ID0069-0197_470f74a3-f9ef-4a24-9bcd-aa54a3538ea9
NDC0069-0197
Product TypeHuman Prescription Drug
Proprietary NameVizimpro
Generic NameDacomitinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-04
Marketing CategoryNDA / NDA
Application NumberNDA211288
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameDACOMITINIB
Active Ingredient Strength15 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0069-0197-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)
Marketing Start Date2018-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0197-30 [00069019730]

Vizimpro TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA211288
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-04

Drug Details

Active Ingredients

IngredientStrength
DACOMITINIB15 mg/1

OpenFDA Data

SPL SET ID:4ab27d2f-e385-4e9c-b324-fa69c10b855a
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0069-0197Vizimprodacomitinib
    0069-1198Vizimprodacomitinib
    0069-2299Vizimprodacomitinib
    63539-197Vizimprodacomitinib

    Trademark Results [Vizimpro]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIZIMPRO
    VIZIMPRO
    85979594 4401809 Live/Registered
    Pfizer Inc.
    2010-12-08
    VIZIMPRO
    VIZIMPRO
    85193224 not registered Dead/Abandoned
    PF PRISM C.V.
    2010-12-08
    VIZIMPRO
    VIZIMPRO
    77235981 not registered Dead/Abandoned
    Pfizer Inc.
    2007-07-23

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