NDC 50881-026

PEMAZYRE

Pemigatinib

PEMAZYRE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Incyte Corporation. The primary component is Pemigatinib.

Product ID50881-026_0954b874-3869-42e6-9d21-6a86108bb2ea
NDC50881-026
Product TypeHuman Prescription Drug
Proprietary NamePEMAZYRE
Generic NamePemigatinib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-04-17
Marketing CategoryNDA / NDA
Application NumberNDA213736
Labeler NameIncyte Corporation
Substance NamePEMIGATINIB
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50881-026-01

14 TABLET in 1 BOTTLE, PLASTIC (50881-026-01)
Marketing Start Date2020-04-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50881-026-01 [50881002601]

PEMAZYRE TABLET
Marketing CategoryNDA
Application NumberNDA213736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-17

Drug Details

Active Ingredients

IngredientStrength
PEMIGATINIB4.5 mg/1

OpenFDA Data

SPL SET ID:9e1f2222-1d89-4e63-989c-ccebe2ab1eb4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2359334
  • 2359344
  • 2359346
  • 2359340
  • 2359342
  • 2359348
  • NDC Crossover Matching brand name "PEMAZYRE" or generic name "Pemigatinib"

    NDCBrand NameGeneric Name
    50881-026PEMAZYREpemigatinib
    50881-027PEMAZYREpemigatinib
    50881-028PEMAZYREpemigatinib

    Trademark Results [PEMAZYRE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEMAZYRE
    PEMAZYRE
    88895503 not registered Live/Pending
    Incyte Holdings Corporation
    2020-04-30
    PEMAZYRE
    PEMAZYRE
    88616570 not registered Live/Pending
    INCYTE HOLDINGS CORPORATION
    2019-09-13
    PEMAZYRE
    PEMAZYRE
    87822632 not registered Live/Pending
    Incyte Holdings Corporation
    2018-03-06

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