NDC 59212-111

Nilandron

Nilutamide

Nilandron is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is Nilutamide.

Product ID59212-111_1c7bf50a-82ee-49ac-b1bc-35d1a2e60f36
NDC59212-111
Product TypeHuman Prescription Drug
Proprietary NameNilandron
Generic NameNilutamide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-07-15
Marketing CategoryNDA / NDA
Application NumberNDA020169
Labeler NameConcordia Pharmaceuticals Inc.
Substance NameNILUTAMIDE
Active Ingredient Strength150 mg/1
Pharm ClassesAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59212-111-14

3 BLISTER PACK in 1 CARTON (59212-111-14) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2013-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59212-111-10 [59212011110]

Nilandron TABLET
Marketing CategoryNDA
Application NumberNDA020169
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-01
Marketing End Date2018-10-25

NDC 59212-111-14 [59212011114]

Nilandron TABLET
Marketing CategoryNDA
Application NumberNDA020169
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-15

Drug Details

Active Ingredients

IngredientStrength
NILUTAMIDE150 mg/1

OpenFDA Data

SPL SET ID:5ccf0e9a-8935-4c8c-b883-b4967281eb4a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311982
  • 284551
  • UPC Code
  • 0359212111142
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Nilandron" or generic name "Nilutamide"

    NDCBrand NameGeneric Name
    59212-111NilandronNilutamide
    82454-0111NilandronNilutamide
    62559-173NilutamideNilutamide
    66993-212NilutamideNilutamide
    82454-0212NilutamideNilutamide

    Trademark Results [Nilandron]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NILANDRON
    NILANDRON
    74646174 1949186 Live/Registered
    CONCORDIA PHARMACEUTICALS INC.
    1995-03-13

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