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United States · US · US:55154-2633_cc868448-2155-45e6-a13b-72bc0d0f0fc8

Ursodiol

In shortageOrange BookUNIISPLATC A05AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeA05AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515426330
    10 BLISTER PACK in 1 BAG (55154-2633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A202540
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ursodiol Capsule
Raw payload (JSON)
{
  "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": "55154-2633_cc868448-2155-45e6-a13b-72bc0d0f0fc8",
  "productndc": "55154-2633",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202540",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Feb 14, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Feb 14, 2013"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA202540",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ursodiol",
  "start_marketing_date": "20241031",
  "active_numerator_strength": "250"
}

Related drugs

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