NDC 65841-613

Bicalutamide

Bicalutamide

Bicalutamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Bicalutamide.

Product ID65841-613_03a74f00-132e-4a48-ba2e-4adf7c3f3170
NDC65841-613
Product TypeHuman Prescription Drug
Proprietary NameBicalutamide
Generic NameBicalutamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-07-06
Marketing CategoryANDA / ANDA
Application NumberANDA079089
Labeler NameZydus Lifesciences Limited
Substance NameBICALUTAMIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAndrogen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-613-01

100 TABLET, FILM COATED in 1 BOTTLE (65841-613-01)
Marketing Start Date2009-07-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-613-01 [65841061301]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-06

NDC 65841-613-06 [65841061306]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-06

NDC 65841-613-05 [65841061305]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-06

NDC 65841-613-30 [65841061330]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-06

NDC 65841-613-10 [65841061310]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-06

Drug Details

Active Ingredients

IngredientStrength
BICALUTAMIDE50 mg/1

OpenFDA Data

SPL SET ID:8e26fbf0-511c-44d9-b484-372d7b50b55e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199123

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0310-0705CASODEXBicalutamide
    62559-680CASODEXBicalutamide
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