NDC 69656-103

ZEJULA

Niraparib

ZEJULA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Niraparib.

Product ID69656-103_260fc974-c8bc-44c5-8f72-b2424254c10a
NDC69656-103
Product TypeHuman Prescription Drug
Proprietary NameZEJULA
Generic NameNiraparib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-03-27
Marketing CategoryNDA / NDA
Application NumberNDA208447
Labeler NameGlaxoSmithKline LLC
Substance NameNIRAPARIB
Active Ingredient Strength100 mg/1
Pharm ClassesPoly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69656-103-30

30 CAPSULE in 1 BOTTLE (69656-103-30)
Marketing Start Date2018-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69656-103-30 [69656010330]

ZEJULA CAPSULE
Marketing CategoryNDA
Application NumberNDA208447
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-01

NDC 69656-103-90 [69656010390]

ZEJULA CAPSULE
Marketing CategoryNDA
Application NumberNDA208447
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-27

Drug Details

Active Ingredients

IngredientStrength
NIRAPARIB100 mg/1

OpenFDA Data

SPL SET ID:0fe9d533-67a9-4981-978a-1e84755ae30b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1918242
  • 1918236
  • Pharmacological Class

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

    Trademark Results [ZEJULA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZEJULA
    ZEJULA
    87213729 5252531 Live/Registered
    Tesaro, Inc.
    2016-10-24
    ZEJULA
    ZEJULA
    87051253 5242730 Live/Registered
    Tesaro, Inc.
    2016-05-26

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.