nilandron

Generic: nilutamide

Labeler: advanz pharma (us) corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nilandron
Generic Name nilutamide
Labeler advanz pharma (us) corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nilutamide 150 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-111
Product ID 59212-111_39a857e5-2f33-4aed-bd5d-58db8da8ab31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020169
Marketing Start 2013-07-15
Marketing End 2026-03-31

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 59212111
Hyphenated Format 59212-111

Supplemental Identifiers

RxCUI
284551 311982
UPC
0359212111142
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 nilandron (source: ndc)
Generic Name nilutamide (source: ndc)
Application Number NDA020169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (59212-111-14) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

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

Ingredients (1)

nilutamide (150 mg/1)

Linked Drug Pages (1)

Nilandron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39a857e5-2f33-4aed-bd5d-58db8da8ab31", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0359212111142"], "unii": ["51G6I8B902"], "rxcui": ["284551", "311982"], "spl_set_id": ["5ccf0e9a-8935-4c8c-b883-b4967281eb4a"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (59212-111-14)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "59212-111-14", "marketing_end_date": "20260331", "marketing_start_date": "20130715"}], "brand_name": "Nilandron", "product_id": "59212-111_39a857e5-2f33-4aed-bd5d-58db8da8ab31", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "59212-111", "generic_name": "Nilutamide", "labeler_name": "Advanz Pharma (US) Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nilandron", "active_ingredients": [{"name": "NILUTAMIDE", "strength": "150 mg/1"}], "application_number": "NDA020169", "marketing_category": "NDA", "marketing_end_date": "20260331", "marketing_start_date": "20130715"}