ZITUVIMET

{
  "unii": {
    "unii": "786Z46389E",
    "rxcui": "235743",
    "inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
    "display_name": "METFORMIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2f635b36-e86a-4e53-8eaf-589917b5f342": {
      "match": "brand_token",
      "title": "ZITUVIMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-01-06"
    }
  },
  "productid": "70771-1859_3bf9383a-afe0-4989-b952-50c995bd3fa5",
  "productndc": "70771-1859",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216743",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG;50MG",
        "product_no": "001",
        "approval_date": "Nov 3, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM;50MG",
        "product_no": "002",
        "approval_date": "Nov 3, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SITAGLIPTIN",
  "proprietary_name": "ZITUVIMET",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA216743",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sitagliptin and Metformin Hydrochloride",
  "start_marketing_date": "20240314",
  "active_numerator_strength": "500; 50"
}