{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0469-0725",
      "generic_name": "enzalutamide",
      "labeler_name": "Astellas Pharma US, Inc.",
      "brand_name": "Xtandi",
      "active_ingredients": [
        {
          "name": "ENZALUTAMIDE",
          "strength": "80 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0469-0725-60",
          "description": "1 BOTTLE in 1 CARTON (0469-0725-60)  / 60 TABLET in 1 BOTTLE",
          "marketing_start_date": "20200804",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Astellas Pharma US, Inc."
        ],
        "rxcui": [
          "1307303",
          "1307309",
          "2390644",
          "2390646",
          "2390648",
          "2390650"
        ],
        "spl_set_id": [
          "b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0304690125990",
          "0304690725602"
        ],
        "nui": [
          "N0000175560",
          "N0000000243",
          "N0000185506",
          "N0000185507",
          "N0000185607"
        ],
        "pharm_class_epc": [
          "Androgen Receptor Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Androgen Receptor Antagonists [MoA]",
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]"
        ],
        "unii": [
          "93T0T9GKNU"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "TABLET",
      "spl_id": "1cc0ed2a-2c33-4027-90bb-572d717b81d2",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20200804",
      "product_id": "0469-0725_1cc0ed2a-2c33-4027-90bb-572d717b81d2",
      "application_number": "NDA213674",
      "brand_name_base": "Xtandi",
      "pharm_class": [
        "Androgen Receptor Antagonists [MoA]",
        "Androgen Receptor Inhibitor [EPC]",
        "Cytochrome P450 2C19 Inducers [MoA]",
        "Cytochrome P450 2C9 Inducers [MoA]",
        "Cytochrome P450 3A4 Inducers [MoA]"
      ]
    }
  ]
}