NDC 57962-420

Imbruvica

Ibrutinib

Imbruvica is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmacyclics Llc. The primary component is Ibrutinib.

Product ID57962-420_0d02fa60-b63e-4a9d-9db2-0138cd052b33
NDC57962-420
Product TypeHuman Prescription Drug
Proprietary NameImbruvica
Generic NameIbrutinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-02-16
Marketing CategoryNDA / NDA
Application NumberNDA210563
Labeler NamePharmacyclics LLC
Substance NameIBRUTINIB
Active Ingredient Strength420 mg/1
Pharm ClassesKinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 57962-420-28

1 BLISTER PACK in 1 CARTON (57962-420-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57962-420-71 [57962042071]

Imbruvica TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

NDC 57962-420-28 [57962042028]

Imbruvica TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-16

Drug Details

Active Ingredients

IngredientStrength
IBRUTINIB420 mg/1

OpenFDA Data

SPL SET ID:0dfd0279-ff17-4ea9-89be-9803c71bab44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1442992
  • 1442986
  • 2000017
  • 1994362
  • 2000019
  • 2000029
  • 2000023
  • 2000031
  • 2000021
  • 2000027
  • 2000025
  • 1994360
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Imbruvica" or generic name "Ibrutinib"

    NDCBrand NameGeneric Name
    57962-007ImbruvicaIbrutinib
    57962-014ImbruvicaIbrutinib
    57962-070ImbruvicaIbrutinib
    57962-140ImbruvicaIbrutinib
    57962-280ImbruvicaImbruvica
    57962-420ImbruvicaImbruvica
    57962-560ImbruvicaImbruvica

    Trademark Results [Imbruvica]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IMBRUVICA
    IMBRUVICA
    86012748 not registered Dead/Abandoned
    Pharmacyclics, Inc.
    2013-07-17
    IMBRUVICA
    IMBRUVICA
    86007097 4523481 Live/Registered
    Pharmacyclics, Inc.
    2013-07-10

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