NDC 68382-224

Bicalutamide

Bicalutamide

Bicalutamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Bicalutamide.

Product ID68382-224_37277718-5eba-4747-b75d-6924663f9c89
NDC68382-224
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 Pharmaceuticals (USA) Inc.
Substance NameBICALUTAMIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-224-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-224-01)
Marketing Start Date2009-07-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-224-30 [68382022430]

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

NDC 68382-224-06 [68382022406]

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

NDC 68382-224-05 [68382022405]

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

NDC 68382-224-01 [68382022401]

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

NDC 68382-224-10 [68382022410]

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

NDC 68382-224-77 [68382022477]

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:d0348cf0-f79a-4579-86c9-a5d25d688659
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199123

    • Pharmacological Class

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

    Medicade Reported Pricing

    68382022406 BICALUTAMIDE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382022401 BICALUTAMIDE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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