Tivicay

{
  "unii": {
    "unii": "1Q1V9V5WYQ",
    "rxcui": "1433867",
    "inchikey": "UGWJRRXTMKRYNK-VSLILLSYSA-M",
    "display_name": "DOLUTEGRAVIR SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "485bc9db-8665-9f5a-e063-6394a90a7921": {
      "match": "brand_token",
      "title": "TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "49702-227_a9175b83-2200-4bd2-9ee3-52095b5d2657",
  "productndc": "49702-227",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204790",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Aug 12, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jun 9, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jun 9, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOLUTEGRAVIR SODIUM",
  "proprietary_name": "Tivicay",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204790",
  "marketing_category": "NDA",
  "nonproprietary_name": "dolutegravir sodium",
  "start_marketing_date": "20160609",
  "active_numerator_strength": "25"
}