XIGDUO

{
  "unii": {
    "unii": "887K2391VH",
    "rxcui": "1486966",
    "inchikey": "GOADIQFWSVMMRJ-UPGAGZFNSA-N",
    "display_name": "DAPAGLIFLOZIN PROPANEDIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ac8a0f7b-9f69-4495-abbc-3a47cd75a859": {
      "match": "brand_token",
      "title": "XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "38",
      "published_date": "2025-01-23"
    }
  },
  "productid": "0310-6225_a8717b28-9445-4292-9ac7-e979f378d9c8",
  "productndc": "0310-6225",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205649",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "001",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;1GM",
        "product_no": "002",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;500MG",
        "product_no": "003",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;1GM",
        "product_no": "004",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG;1GM",
        "product_no": "005",
        "approval_date": "Jul 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "XIGDUO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205649",
  "marketing_category": "NDA",
  "nonproprietary_name": "dapagliflozin and metformin hydrochloride",
  "start_marketing_date": "20141029",
  "active_numerator_strength": "2.5; 1000"
}