NDC 71335-0765

Bicalutamide

Bicalutamide

Bicalutamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Bicalutamide.

Product ID71335-0765_3e1622b3-c323-44ac-ba08-2ef16997f5c3
NDC71335-0765
Product TypeHuman Prescription Drug
Proprietary NameBicalutamide
Generic NameBicalutamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-07-06
Marketing CategoryANDA / ANDA
Application NumberANDA076932
Labeler NameBryant Ranch Prepack
Substance NameBICALUTAMIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0765-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0765-1)
Marketing Start Date2016-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0765-2 [71335076502]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076932
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-02
Inactivation Date2020-01-31

NDC 71335-0765-1 [71335076501]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076932
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-02
Inactivation Date2020-01-31

NDC 71335-0765-3 [71335076503]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076932
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BICALUTAMIDE50 mg/1

OpenFDA Data

SPL SET ID:a420376b-d5c9-4e18-bf1f-1dbf7f5e7baa
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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