NDC 59676-600

ERLEADA

Apalutamide

ERLEADA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Products, Lp. The primary component is Apalutamide.

Product ID59676-600_523d6f2a-09c8-11ea-b5b8-6c57192adfa6
NDC59676-600
Product TypeHuman Prescription Drug
Proprietary NameERLEADA
Generic NameApalutamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-02-14
Marketing CategoryNDA / NDA
Application NumberNDA210951
Labeler NameJanssen Products, LP
Substance NameAPALUTAMIDE
Active Ingredient Strength60 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59676-600-12

120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)
Marketing Start Date2018-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59676-600-12 [59676060012]

ERLEADA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-14

NDC 59676-600-99 [59676060099]

ERLEADA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210951
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-14

NDC 59676-600-56 [59676060056]

ERLEADA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210951
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
APALUTAMIDE60 mg/1

OpenFDA Data

SPL SET ID:d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1999587
  • 1999581

    • Trademark Results [ERLEADA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ERLEADA
    ERLEADA
    86967766 5492719 Live/Registered
    JOHNSON & JOHNSON
    2016-04-07
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.