Harvoni

{
  "unii": {
    "unii": "013TE6E4WV",
    "rxcui": "1591922",
    "inchikey": "VRTWBAAJJOHBQU-KMWAZVGDSA-N",
    "display_name": "LEDIPASVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1a1c555d-2fdf-4150-8ace-dbc770c226bf": {
      "match": "brand_token",
      "title": "HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]",
      "spl_version": "10",
      "published_date": "2025-06-23"
    }
  },
  "productid": "61958-1801_6fc15183-879a-4402-af66-edf57754e31f",
  "productndc": "61958-1801",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205834",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "90MG;400MG",
        "product_no": "001",
        "approval_date": "Oct 10, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "45MG;200MG",
        "product_no": "002",
        "approval_date": "Aug 28, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEDIPASVIR; SOFOSBUVIR",
  "proprietary_name": "Harvoni",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205834",
  "marketing_category": "NDA",
  "nonproprietary_name": "LEDIPASVIR and SOFOSBUVIR",
  "start_marketing_date": "20141010",
  "active_numerator_strength": "90; 400"
}