Trintellix

{
  "unii": {
    "unii": "TKS641KOAY",
    "rxcui": "1439834",
    "inchikey": "VNGRUFUIHGGOOM-UHFFFAOYSA-N",
    "display_name": "VORTIOXETINE HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "239215eb-be32-4286-9677-1e5556c6cccf": {
      "match": "brand_token",
      "title": "TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.]",
      "spl_version": "4",
      "published_date": "2026-04-27"
    }
  },
  "productid": "55154-0257_7b53e0ea-8161-474c-b623-734841128a9a",
  "productndc": "55154-0257",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204447",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 30, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Sep 30, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Sep 30, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Sep 30, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VORTIOXETINE HYDROBROMIDE",
  "proprietary_name": "Trintellix",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204447",
  "marketing_category": "NDA",
  "nonproprietary_name": "vortioxetine",
  "start_marketing_date": "20131002",
  "active_numerator_strength": "20"
}