nilutamide

Generic: nilutamide

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name nilutamide
Generic Name nilutamide
Labeler prasco laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nilutamide 150 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-212
Product ID 66993-212_aeadbd73-eec6-4323-b3f9-88c39d7cd972
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020169
Marketing Start 2019-11-22
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 66993212
Hyphenated Format 66993-212

Supplemental Identifiers

RxCUI
311982
UPC
0366993212388
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 NDA020169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (66993-212-38) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

66993-212-38 3 BLISTER PACK in 1 CARTON (66993-212-38) / 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": "aeadbd73-eec6-4323-b3f9-88c39d7cd972", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0366993212388"], "unii": ["51G6I8B902"], "rxcui": ["311982"], "spl_set_id": ["34ea4810-2d6c-4bd9-ae52-8bab786dee91"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (66993-212-38)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "66993-212-38", "marketing_end_date": "20260331", "marketing_start_date": "20191122"}], "brand_name": "Nilutamide", "product_id": "66993-212_aeadbd73-eec6-4323-b3f9-88c39d7cd972", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "66993-212", "generic_name": "Nilutamide", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nilutamide", "active_ingredients": [{"name": "NILUTAMIDE", "strength": "150 mg/1"}], "application_number": "NDA020169", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260331", "marketing_start_date": "20191122"}