NDC 63020-534

Iclusig

Ponatinib Hydrochloride

Iclusig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Millennium Pharmaceuticals, Inc.. The primary component is Ponatinib Hydrochloride.

Product ID63020-534_0277cb2e-ac32-4fd4-83a4-a3132984e934
NDC63020-534
Product TypeHuman Prescription Drug
Proprietary NameIclusig
Generic NamePonatinib Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-12-14
Marketing CategoryNDA / NDA
Application NumberNDA203469
Labeler NameMillennium Pharmaceuticals, Inc.
Substance NamePONATINIB HYDROCHLORIDE
Active Ingredient Strength45 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63020-534-30

30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30)
Marketing Start Date2012-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63020-534-30 [63020053430]

Iclusig TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-14

Drug Details

Active Ingredients

IngredientStrength
PONATINIB HYDROCHLORIDE45 mg/1

OpenFDA Data

SPL SET ID:16d804b6-4957-43ee-b18c-3b36ec37c5ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1364352
  • 1364358
  • 1726639
  • 1364360
  • 1364362
  • 1726637
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Iclusig" or generic name "Ponatinib Hydrochloride"

    NDCBrand NameGeneric Name
    63020-533Iclusigponatinib hydrochloride
    63020-534Iclusigponatinib hydrochloride
    63020-535Iclusigponatinib hydrochloride
    63020-536Iclusigponatinib hydrochloride
    76189-533Iclusigponatinib hydrochloride
    76189-534Iclusigponatinib hydrochloride
    76189-535Iclusigponatinib hydrochloride

    Trademark Results [Iclusig]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ICLUSIG
    ICLUSIG
    85254659 4324899 Live/Registered
    ARIAD Pharmaceuticals, Inc.
    2011-03-01

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