NDC 16714-571

Bicalutamide

Bicalutamide

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

Product ID16714-571_963fe7a5-8c45-4071-8017-96f033a17d48
NDC16714-571
Product TypeHuman Prescription Drug
Proprietary NameBicalutamide
Generic NameBicalutamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-08-28
Marketing CategoryANDA / ANDA
Application NumberANDA078634
Labeler NameNorthstar RxLLC
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 16714-571-02

100 TABLET, FILM COATED in 1 BOTTLE (16714-571-02)
Marketing Start Date2009-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-571-02 [16714057102]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078634
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-28
Marketing End Date2019-09-30

NDC 16714-571-01 [16714057101]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078634
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-28
Marketing End Date2019-09-30

NDC 16714-571-03 [16714057103]

Bicalutamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078634
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-28
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
BICALUTAMIDE50 mg/1

OpenFDA Data

SPL SET ID:f03d7e7a-cbe9-4788-894c-d30739f7e733
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199123

    • Pharmacological Class

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

    Medicade Reported Pricing

    16714057102 BICALUTAMIDE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    16714057101 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.