NDC 50881-005

JAKAFI

Ruxolitinib

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

Product ID50881-005_00b95a6b-5e0f-4084-9761-ed13709c4458
NDC50881-005
Product TypeHuman Prescription Drug
Proprietary NameJAKAFI
Generic NameRuxolitinib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-11-16
Marketing CategoryNDA / NDA
Application NumberNDA202192
Labeler NameIncyte Corporation
Substance NameRUXOLITINIB
Active Ingredient Strength5 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50881-005-60

60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60)
Marketing Start Date2011-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50881-005-60 [50881000560]

JAKAFI TABLET
Marketing CategoryNDA
Application NumberNDA202192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-16

Drug Details

Active Ingredients

IngredientStrength
RUXOLITINIB5 mg/1

OpenFDA Data

SPL SET ID:f1c82580-87ae-11e0-bc84-0002a5d5c51b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1193349
  • 1193343
  • 1193341
  • 1193351
  • 1193347
  • 1193353
  • 1193345
  • 1193339
  • 1193337
  • 1193331
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]

    NDC Crossover Matching brand name "JAKAFI" or generic name "Ruxolitinib"

    NDCBrand NameGeneric Name
    50881-005JAKAFIruxolitinib
    50881-010JAKAFIruxolitinib
    50881-015JAKAFIruxolitinib
    50881-020JAKAFIruxolitinib
    50881-025JAKAFIruxolitinib
    50881-007OPZELURAruxolitinib

    Trademark Results [JAKAFI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JAKAFI
    JAKAFI
    85569591 4267302 Live/Registered
    INCYTE HOLDINGS CORPORATION
    2012-03-14
    JAKAFI
    JAKAFI
    85280226 4126784 Live/Registered
    INCYTE HOLDINGS CORPORATION
    2011-03-29

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