ALYFTREK

{
  "unii": {
    "unii": "SHA6U5FJZL",
    "rxcui": null,
    "inchikey": "PURKAOJPTOLRMP-ASMGOKTBSA-N",
    "display_name": "DEUTIVACAFTOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7e635909-c6fd-4f0d-ae77-cdff03653a20": {
      "match": "brand_token",
      "title": "ALYFTREK (VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED]",
      "spl_version": "8",
      "published_date": "2026-04-08"
    }
  },
  "productid": "51167-121_9b4cc7f5-485c-42a5-ab1c-748b441cc9e7",
  "productndc": "51167-121",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218730",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;20MG;EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Dec 20, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "125MG;50MG;EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Dec 20, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR",
  "proprietary_name": "ALYFTREK",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA218730",
  "marketing_category": "NDA",
  "nonproprietary_name": "vanzacaftor, tezacaftor, and deutivacaftor",
  "start_marketing_date": "20241220",
  "active_numerator_strength": "125; 50; 10"
}