JANUMET

{
  "unii": {
    "unii": "786Z46389E",
    "rxcui": "235743",
    "inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
    "display_name": "METFORMIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50": {
      "match": "brand_token",
      "title": "JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME LLC]",
      "spl_version": "43",
      "published_date": "2025-03-31"
    }
  },
  "productid": "50090-5502_7511c56d-21ea-4bad-89b9-62329c2e3d75",
  "productndc": "50090-5502",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022044",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG;EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Mar 30, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1GM;EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Mar 30, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE",
  "proprietary_name": "JANUMET",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022044",
  "marketing_category": "NDA",
  "nonproprietary_name": "SITAGLIPTIN and METFORMIN HYDROCHLORIDE",
  "start_marketing_date": "20070330",
  "active_numerator_strength": "1000; 50"
}