{
  "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": "51167-809",
      "generic_name": "lumacaftor and ivacaftor",
      "labeler_name": "Vertex Pharmaceuticals Incorporated",
      "brand_name": "ORKAMBI",
      "active_ingredients": [
        {
          "name": "LUMACAFTOR",
          "strength": "200 mg/1"
        },
        {
          "name": "IVACAFTOR",
          "strength": "125 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "51167-809-01",
          "description": "4 CARTON in 1 BOX (51167-809-01)  / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20150702",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Vertex Pharmaceuticals Incorporated"
        ],
        "rxcui": [
          "1655928",
          "1655934",
          "1812468",
          "1812470",
          "2053509",
          "2053512",
          "2053517",
          "2053519",
          "2611458",
          "2611460"
        ],
        "spl_set_id": [
          "3fc1c40e-cfac-47a1-9e1a-61ead3570600"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000184146",
          "N0000184145",
          "N0000185504",
          "N0000185503",
          "N0000190114",
          "N0000190118",
          "N0000187064",
          "N0000187063",
          "N0000185507",
          "N0000185607",
          "N0000187062",
          "N0000191264"
        ],
        "pharm_class_epc": [
          "Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]"
        ],
        "pharm_class_moa": [
          "Chloride Channel Activation Potentiators [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]",
          "Cytochrome P450 3A Inducers [MoA]",
          "Cytochrome P450 2B6 Inducers [MoA]",
          "Cytochrome P450 2C8 Inducers [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "P-Glycoprotein Inducers [MoA]"
        ],
        "unii": [
          "1Y740ILL1Z",
          "EGP8L81APK"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "e746b83a-cec1-40ab-8dba-7d8c1781e8b1",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20150702",
      "product_id": "51167-809_e746b83a-cec1-40ab-8dba-7d8c1781e8b1",
      "application_number": "NDA206038",
      "brand_name_base": "ORKAMBI",
      "pharm_class": [
        "Chloride Channel Activation Potentiators [MoA]",
        "Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]",
        "Cytochrome P450 2B6 Inducers [MoA]",
        "Cytochrome P450 2C19 Inducers [MoA]",
        "Cytochrome P450 2C8 Inducers [MoA]",
        "Cytochrome P450 2C8 Inhibitors [MoA]",
        "Cytochrome P450 2C9 Inducers [MoA]",
        "Cytochrome P450 2C9 Inhibitors [MoA]",
        "Cytochrome P450 2C9 Inhibitors [MoA]",
        "Cytochrome P450 3A Inducers [MoA]",
        "Cytochrome P450 3A Inhibitors [MoA]",
        "P-Glycoprotein Inducers [MoA]",
        "P-Glycoprotein Inhibitors [MoA]",
        "P-Glycoprotein Inhibitors [MoA]"
      ]
    }
  ]
}