{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0074-0039",
      "generic_name": "Elagolix",
      "labeler_name": "AbbVie Inc.",
      "brand_name": "Orilissa",
      "active_ingredients": [
        {
          "name": "ELAGOLIX SODIUM",
          "strength": "200 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0074-0039-14",
          "description": "1 BLISTER PACK in 1 CARTON (0074-0039-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20180723",
          "sample": true
        },
        {
          "package_ndc": "0074-0039-56",
          "description": "4 BLISTER PACK in 1 CARTON (0074-0039-56)  / 14 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20180723",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "AbbVie Inc."
        ],
        "rxcui": [
          "2049852",
          "2049858",
          "2049860",
          "2049862"
        ],
        "spl_set_id": [
          "a86757b3-09c5-fd3b-1223-244e94f50a66"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5948VUI423"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "07f98869-6203-4e8c-b576-2ba8f0a159d7",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20180723",
      "product_id": "0074-0039_07f98869-6203-4e8c-b576-2ba8f0a159d7",
      "application_number": "NDA210450",
      "brand_name_base": "Orilissa",
      "pharm_class": [
        "Cytochrome P450 2C19 Inhibitors [MoA]",
        "Cytochrome P450 3A Inducers [MoA]",
        "Decreased GnRH Secretion [PE]",
        "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]",
        "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]",
        "P-Glycoprotein Inhibitors [MoA]"
      ]
    }
  ]
}