Ursodiol

{
  "unii": {
    "unii": "724L30Y2QR",
    "rxcui": "11065",
    "inchikey": "RUDATBOHQWOJDD-UZVSRGJWSA-N",
    "display_name": "URSODIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fb317988-a4e3-9c9a-e053-6294a90a5990": {
      "match": "brand_token",
      "title": "URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "4",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0591-3159_0e26efeb-af94-41b0-be24-cf5095f9260e",
  "productndc": "0591-3159",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "019594",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 31, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 31, 1987"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "URSODIOL",
  "shortage_reason": "Ursodiol Capsule",
  "shortage_status": "current",
  "proprietary_name": "Ursodiol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019594",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Ursodiol",
  "start_marketing_date": "19871231",
  "active_numerator_strength": "300"
}