{
  "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": "63090-665",
      "generic_name": "trofinetide",
      "labeler_name": "Acadia Pharmaceuticals Inc.",
      "brand_name": "Daybue Stix",
      "active_ingredients": [
        {
          "name": "TROFINETIDE",
          "strength": "8000 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "63090-665-60",
          "description": "60 PACKET in 1 CARTON (63090-665-60)  / 1 FOR SOLUTION in 1 PACKET (63090-665-01)",
          "marketing_start_date": "20251211",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Acadia Pharmaceuticals Inc."
        ],
        "rxcui": [
          "2632857",
          "2632863",
          "2729447",
          "2729451",
          "2729453",
          "2729455",
          "2729457",
          "2729459"
        ],
        "spl_set_id": [
          "67e6f2d9-21f6-466f-9def-826c6a4b8257"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363090660012"
        ],
        "nui": [
          "N0000182141",
          "N0000190107",
          "N0000190108"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"
        ],
        "unii": [
          "Z2ME8F52QL"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "FOR SOLUTION",
      "spl_id": "acf4551a-4f21-46d6-8575-0c553c2c6d39",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20251211",
      "product_id": "63090-665_acf4551a-4f21-46d6-8575-0c553c2c6d39",
      "application_number": "NDA219884",
      "brand_name_base": "Daybue Stix",
      "pharm_class": [
        "Cytochrome P450 3A4 Inhibitors [MoA]",
        "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
        "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"
      ]
    }
  ]
}