Synjardy

{
  "unii": {
    "unii": "HDC1R2M35U",
    "rxcui": "1545653",
    "inchikey": "OBWASQILIWPZMG-QZMOQZSNSA-N",
    "display_name": "EMPAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0fdd0255-0055-65f3-b2c0-db8fbb87beae": {
      "match": "brand_token",
      "title": "SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "22",
      "published_date": "2026-02-02"
    }
  },
  "productid": "0597-0280_09b6e275-e784-41d8-a75d-74a22f3e2eca",
  "productndc": "0597-0280",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208658",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG;1GM",
        "product_no": "001",
        "approval_date": "Dec 9, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG;1GM",
        "product_no": "002",
        "approval_date": "Dec 9, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG;1GM",
        "product_no": "003",
        "approval_date": "Dec 9, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG;1GM",
        "product_no": "004",
        "approval_date": "Dec 9, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Synjardy",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA208658",
  "marketing_category": "NDA",
  "nonproprietary_name": "empagliflozin, metformin hydrochloride",
  "start_marketing_date": "20161210",
  "active_numerator_strength": "10; 1000"
}