NDC 62559-680

CASODEX

Bicalutamide

CASODEX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ani Pharmaceuticals, Inc.. The primary component is Bicalutamide.

Product ID62559-680_09a60ae0-2a64-49f7-88f2-6b06bf3d44b7
NDC62559-680
Product TypeHuman Prescription Drug
Proprietary NameCASODEX
Generic NameBicalutamide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-26
Marketing CategoryNDA / NDA
Application NumberNDA020498
Labeler NameANI Pharmaceuticals, Inc.
Substance NameBICALUTAMIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62559-680-30

30 TABLET in 1 BOTTLE (62559-680-30)
Marketing Start Date2018-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62559-680-30 [62559068030]

CASODEX TABLET
Marketing CategoryNDA
Application NumberNDA020498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-26

Drug Details

Active Ingredients

IngredientStrength
BICALUTAMIDE50 mg/1

OpenFDA Data

SPL SET ID:dfee4fe7-8478-4a3e-925d-00be3cd0ab67
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199123
  • 108828
    • UPC Code
  • 0362559680301

    • Pharmacological Class

    • Androgen Receptor Antagonists [MoA]
    • Androgen Receptor Inhibitor [EPC]

    NDC Crossover Matching brand name "CASODEX" or generic name "Bicalutamide"

    NDCBrand NameGeneric Name
    0310-0705CASODEXBicalutamide
    62559-680CASODEXBicalutamide
    0093-0220BicalutamideBicalutamide
    0904-6019BicalutamideBicalutamide
    16714-571Bicalutamidebicalutamide
    16714-816BicalutamideBicalutamide
    16729-023BicalutamideBicalutamide
    47335-485bicalutamidebicalutamide
    60429-177BicalutamideBicalutamide
    60505-2642BicalutamideBicalutamide
    62559-890BicalutamideBicalutamide
    63629-8308BicalutamideBicalutamide
    63672-0005BicalutamideBicalutamide
    65841-613BicalutamideBicalutamide
    67253-191bicalutamidebicalutamide
    68382-224BicalutamideBicalutamide
    70518-2993BicalutamideBicalutamide
    71205-577BicalutamideBicalutamide
    71335-0765BicalutamideBicalutamide

    Trademark Results [CASODEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CASODEX
    CASODEX
    74261597 not registered Dead/Abandoned
    IMPERIAL CHEMICAL INDUSTRIES PLC
    1992-04-02
    CASODEX
    CASODEX
    73764741 1574288 Live/Registered
    IMPERIAL CHEMICAL INDUSTRIES PLC
    1988-11-21
    CASODEX
    CASODEX
    73616691 1441007 Dead/Cancelled
    IMPERIAL CHEMICAL INDUSTRIES PLC.
    1986-08-25
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.