Trijardy XR

{
  "unii": {
    "unii": "HDC1R2M35U",
    "rxcui": "1545653",
    "inchikey": "OBWASQILIWPZMG-QZMOQZSNSA-N",
    "display_name": "EMPAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "71873567-9594-452a-bb92-34a129adecac": {
      "match": "brand_token",
      "title": "TRIJARDY XR (EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-02-02"
    }
  },
  "productid": "0597-0395_ca86ce8b-9c04-47d8-94e3-ae041f251fab",
  "productndc": "0597-0395",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212614",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG;2.5MG;1GM",
        "product_no": "001",
        "approval_date": "Jan 27, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG;5MG;1GM",
        "product_no": "002",
        "approval_date": "Jan 27, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG;2.5MG;1GM",
        "product_no": "003",
        "approval_date": "Jan 27, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG;5MG;1GM",
        "product_no": "004",
        "approval_date": "Jan 27, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Trijardy XR",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA212614",
  "marketing_category": "NDA",
  "nonproprietary_name": "empagliflozin, linagliptin, metformin hydrochloride",
  "start_marketing_date": "20200423",
  "active_numerator_strength": "5; 2.5; 1000"
}