NDC 62559-173

Nilutamide

Nilutamide

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

• Product ID: 62559-173_441002fd-1e82-482c-acab-560838b7118f
• NDC: 62559-173
• Product Type: Human Prescription Drug
• Proprietary Name: Nilutamide
• Generic Name: Nilutamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207631
• Labeler Name: ANI 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: 2021-12-31

Packaging

NDC 62559-173-31

3 BLISTER PACK in 1 CARTON (62559-173-31) > 10 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2016-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62559-173-31 [62559017331]

Nilutamide TABLET

• Marketing Category: ANDA
• Application Number: ANDA207631
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-18

Drug Details

Active Ingredients

Ingredient	Strength
NILUTAMIDE	150 mg/1

OpenFDA Data

• SPL SET ID: d5740b8f-fbb3-4023-9133-9e359a9ab980
• Manufacturer:
  • ANI Pharmaceuticals, Inc.
• UNII:
  • 51G6I8B902
• RxNorm Concept Unique ID - RxCUI:
  • 311982

Pharmacological Class

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

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

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