ORKAMBI

{
  "unii": {
    "unii": "1Y740ILL1Z",
    "rxcui": "1243041",
    "inchikey": "PURKAOJPTOLRMP-UHFFFAOYSA-N",
    "display_name": "IVACAFTOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3fc1c40e-cfac-47a1-9e1a-61ead3570600": {
      "match": "brand_token",
      "title": "ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED ORKAMBI (LUMACAFTOR AND IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED]",
      "spl_version": "24",
      "published_date": "2026-03-31"
    }
  },
  "productid": "51167-700_e746b83a-cec1-40ab-8dba-7d8c1781e8b1",
  "productndc": "51167-700",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206038",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "125MG;200MG",
        "product_no": "001",
        "approval_date": "Jul 2, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "125MG;100MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVACAFTOR; LUMACAFTOR",
  "proprietary_name": "ORKAMBI",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA206038",
  "marketing_category": "NDA",
  "nonproprietary_name": "lumacaftor and ivacaftor",
  "start_marketing_date": "20160928",
  "active_numerator_strength": "125; 100"
}