NDC 63672-0005

Bicalutamide

Bicalutamide

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

Product ID63672-0005_65ee30e3-b0ed-4150-b590-95387ed3a991
NDC63672-0005
Product TypeHuman Prescription Drug
Proprietary NameBicalutamide
Generic NameBicalutamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-07-06
Marketing CategoryANDA / ANDA
Application NumberANDA077973
Labeler NameSynthon Pharmaceuticals, Inc.
Substance NameBICALUTAMIDE
Active Ingredient Strength50 mg/1
Pharm ClassesAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63672-0005-0

50000 TABLET, FILM COATED in 1 DRUM (63672-0005-0)
Marketing Start Date2009-07-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63672-0005-0 [63672000500]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077973
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-06
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
BICALUTAMIDE50 mg/1

OpenFDA Data

SPL SET ID:c267f783-1d39-4f27-83ed-8288577bf66d
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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.