Xtandi

Orange BookUNIISPLATC L02BB04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAstellas Pharma US, Inc.

CountryUS (United States)

ATC codeL02BB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0469172556
1 BOTTLE in 1 CARTON (0469-1725-56) / 56 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

93T0T9GKNU

ENZALUTAMIDE

RxCUI 1307298

Orange Book

N213674

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "93T0T9GKNU",
    "rxcui": "1307298",
    "inchikey": "WXCXUHSOUPDCQV-UHFFFAOYSA-N",
    "display_name": "ENZALUTAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf": {
      "match": "brand_token",
      "title": "XTANDI (ENZALUTAMIDE) CAPSULE XTANDI (ENZALUTAMIDE) TABLET [ASTELLAS PHARMA US, INC.]",
      "spl_version": "22",
      "published_date": "2025-12-18"
    }
  },
  "productid": "0469-1725_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e",
  "productndc": "0469-1725",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213674",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Aug 4, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Aug 4, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENZALUTAMIDE",
  "proprietary_name": "Xtandi",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213674",
  "marketing_category": "NDA",
  "nonproprietary_name": "enzalutamide",
  "start_marketing_date": "20200804",
  "active_numerator_strength": "40"
}

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