Kalydeco

{
  "unii": {
    "unii": "1Y740ILL1Z",
    "rxcui": "1243041",
    "inchikey": "PURKAOJPTOLRMP-UHFFFAOYSA-N",
    "display_name": "IVACAFTOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25": {
      "match": "brand_token",
      "title": "KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]",
      "spl_version": "36",
      "published_date": "2026-03-30"
    }
  },
  "productid": "51167-785_13eb3fc2-0dac-4ada-96a8-a2e0cea711b7",
  "productndc": "51167-785",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "207925",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG/PACKET",
        "product_no": "001",
        "approval_date": "Mar 17, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "75MG/PACKET",
        "product_no": "002",
        "approval_date": "Mar 17, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG/PACKET",
        "product_no": "003",
        "approval_date": "Apr 29, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5.8MG/PACKET",
        "product_no": "004",
        "approval_date": "May 3, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "13.4MG/PACKET",
        "product_no": "005",
        "approval_date": "May 3, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVACAFTOR",
  "proprietary_name": "Kalydeco",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207925",
  "marketing_category": "NDA",
  "nonproprietary_name": "ivacaftor",
  "start_marketing_date": "20230503",
  "active_numerator_strength": "5.8"
}