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United States · US · US:62559-173_441002fd-1e82-482c-acab-560838b7118f

Nilutamide

In shortageOrange BookUNIIATC L02BB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL02BB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6255917331
    3 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
51G6I8B902
NILUTAMIDE
RxCUI 31805
Orange Book
A207631
FDA shortage
Currently in shortage
Nilutamide Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "51G6I8B902",
    "rxcui": "31805",
    "inchikey": "XWXYUMMDTVBTOU-UHFFFAOYSA-N",
    "display_name": "NILUTAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "62559-173_441002fd-1e82-482c-acab-560838b7118f",
  "productndc": "62559-173",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207631",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jul 15, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NILUTAMIDE",
  "shortage_reason": "Nilutamide Tablet",
  "shortage_status": "current",
  "proprietary_name": "Nilutamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207631",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nilutamide",
  "start_marketing_date": "20160718",
  "active_numerator_strength": "150"
}

Related drugs

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