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 ID: 59212-111_1c7bf50a-82ee-49ac-b1bc-35d1a2e60f36
• NDC: 59212-111
• Product Type: Human Prescription Drug
• Proprietary Name: Nilandron
• Generic Name: Nilutamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-15
• Marketing Category: NDA / NDA
• Application Number: NDA020169
• Labeler Name: Concordia Pharmaceuticals Inc.
• Substance Name: NILUTAMIDE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59212-111-14

3 BLISTER PACK in 1 CARTON (59212-111-14) > 10 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2013-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59212-111-10 [59212011110]

Nilandron TABLET

• Marketing Category: NDA
• Application Number: NDA020169
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-01
• Marketing End Date: 2018-10-25

NDC 59212-111-14 [59212011114]

Nilandron TABLET

• Marketing Category: NDA
• Application Number: NDA020169
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-15

Drug Details

Active Ingredients

Ingredient	Strength
NILUTAMIDE	150 mg/1

OpenFDA Data

• SPL SET ID: 5ccf0e9a-8935-4c8c-b883-b4967281eb4a
• Manufacturer:
  • Concordia Pharmaceuticals Inc.
• UNII:
  • 51G6I8B902
• 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"

NDC	Brand Name	Generic Name
59212-111	Nilandron	Nilutamide
82454-0111	Nilandron	Nilutamide
62559-173	Nilutamide	Nilutamide
66993-212	Nilutamide	Nilutamide
82454-0212	Nilutamide	Nilutamide