nilutamide

Generic: nilutamide

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nilutamide
Generic Name nilutamide
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nilutamide 150 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-173
Product ID 62559-173_441002fd-1e82-482c-acab-560838b7118f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207631
Listing Expiration 2026-12-31
Marketing Start 2016-07-18

Pharmacologic Class

Established (EPC)
androgen receptor inhibitor [epc]
Mechanism of Action
androgen receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559173
Hyphenated Format 62559-173

Supplemental Identifiers

RxCUI
311982
UPC
0362559173315
UNII
51G6I8B902
NUI
N0000000243 N0000175560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nilutamide (source: ndc)
Generic Name nilutamide (source: ndc)
Application Number ANDA207631 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

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

Ingredients (1)

nilutamide (150 mg/1)

Linked Drug Pages (1)

Nilutamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "441002fd-1e82-482c-acab-560838b7118f", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0362559173315"], "unii": ["51G6I8B902"], "rxcui": ["311982"], "spl_set_id": ["d5740b8f-fbb3-4023-9133-9e359a9ab980"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (62559-173-31)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "62559-173-31", "marketing_start_date": "20160718"}], "brand_name": "Nilutamide", "product_id": "62559-173_441002fd-1e82-482c-acab-560838b7118f", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "62559-173", "generic_name": "Nilutamide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nilutamide", "active_ingredients": [{"name": "NILUTAMIDE", "strength": "150 mg/1"}], "application_number": "ANDA207631", "marketing_category": "ANDA", "marketing_start_date": "20160718", "listing_expiration_date": "20261231"}