NDC 63539-187

Ibrance

Palbociclib

Ibrance is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Palbociclib.

Product ID63539-187_8720b986-1c77-4b3e-b18e-62213aab1853
NDC63539-187
Product TypeHuman Prescription Drug
Proprietary NameIbrance
Generic NamePalbociclib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-05-08
Marketing CategoryNDA / NDA
Application NumberNDA207103
Labeler NameU.S. Pharmaceuticals
Substance NamePALBOCICLIB
Active Ingredient Strength75 mg/1
Pharm ClassesKinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63539-187-11

21 CAPSULE in 1 BOTTLE (63539-187-11)
Marketing Start Date2017-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63539-187-11 [63539018711]

Ibrance CAPSULE
Marketing CategoryNDA
Application NumberNDA207103
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-08

Drug Details

Active Ingredients

IngredientStrength
PALBOCICLIB75 mg/1

OpenFDA Data

SPL SET ID:86718885-da44-4d3d-b3ca-06cbcedcffd8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1601380
  • 1601392
  • 1601390
  • 1601386
  • 1601394
  • 1601388
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Kinase Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]

    NDC Crossover Matching brand name "Ibrance" or generic name "Palbociclib"

    NDCBrand NameGeneric Name
    0069-0187Ibrancepalbociclib
    0069-0188Ibrancepalbociclib
    0069-0189Ibrancepalbociclib
    0069-0284Ibrancepalbociclib
    0069-0486Ibrancepalbociclib
    0069-0688Ibrancepalbociclib
    63539-187Ibrancepalbociclib
    63539-188Ibrancepalbociclib
    63539-189Ibrancepalbociclib
    63539-284Ibrancepalbociclib
    63539-486Ibrancepalbociclib
    63539-688Ibrancepalbociclib

    Trademark Results [Ibrance]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IBRANCE
    IBRANCE
    86314613 4928206 Live/Registered
    Pfizer Inc.
    2014-06-19
    IBRANCE
    IBRANCE
    85444239 4518147 Live/Registered
    Pfizer Inc.
    2011-10-11
    IBRANCE
    IBRANCE
    77448185 not registered Dead/Abandoned
    Pfizer Inc.
    2008-04-15

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