NDC 0904-6019

Bicalutamide

Bicalutamide

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

Product ID0904-6019_78472a98-e573-47a6-bb12-02621c019ff2
NDC0904-6019
Product TypeHuman Prescription Drug
Proprietary NameBicalutamide
Generic NameBicalutamide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-05-11
Marketing CategoryANDA / ANDA
Application NumberANDA078917
Labeler NameMajor Pharmaceuticals
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 0904-6019-46

30 TABLET in 1 BOTTLE (0904-6019-46)
Marketing Start Date2010-05-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6019-46 [00904601946]

Bicalutamide TABLET
Marketing CategoryANDA
Application NumberANDA078917
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-11

Drug Details

Active Ingredients

IngredientStrength
BICALUTAMIDE50 mg/1

OpenFDA Data

SPL SET ID:82d4877e-6ebf-4f75-a108-28dc840b07fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199123
    • UPC Code
  • 0309046019466

    • 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.