NDC 63539-295

Talzenna

Talazoparib

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

Product ID63539-295_2b72fd4a-5bfe-4c4e-8ab1-b2945e0a072a
NDC63539-295
Product TypeHuman Prescription Drug
Proprietary NameTalzenna
Generic NameTalazoparib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-10-26
Marketing CategoryNDA / NDA
Application NumberNDA211651
Labeler NameU.S. Pharmaceuticals
Substance NameTALAZOPARIB TOSYLATE
Active Ingredient Strength1 mg/1
Pharm ClassesPoly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63539-295-30

30 CAPSULE in 1 BOTTLE (63539-295-30)
Marketing Start Date2018-12-10
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 63539-295-30 [63539029530]

Talzenna CAPSULE
Marketing CategoryNDA
Application NumberNDA211651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-10

Drug Details

Active Ingredients

IngredientStrength
TALAZOPARIB TOSYLATE1 mg/1

OpenFDA Data

SPL SET ID:13839d4f-6acf-4ffb-a128-79df59319273
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2099954
  • 2099956
  • Pharmacological Class

    • Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
    • Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
    • Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
    • Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

    NDC Crossover Matching brand name "Talzenna" or generic name "Talazoparib"

    NDCBrand NameGeneric Name
    0069-0296Talzennatalazoparib
    0069-1195Talzennatalazoparib
    0069-1501Talzennatalazoparib
    0069-1751Talzennatalazoparib
    46014-0296Talzennatalazoparib
    46014-1195Talzennatalazoparib
    63539-295Talzennatalazoparib

    Trademark Results [Talzenna]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TALZENNA
    TALZENNA
    87293680 not registered Dead/Abandoned
    Wyeth LLC
    2017-01-09
    TALZENNA
    TALZENNA
    86253764 5291322 Live/Registered
    Wyeth LLC
    2014-04-16
    TALZENNA
    TALZENNA
    85173532 not registered Dead/Abandoned
    Wyeth LLC
    2010-11-10
    TALZENNA
    TALZENNA
    77180181 not registered Dead/Abandoned
    WYETH LLC
    2007-05-14

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