🇺🇸
United States · US · US:58914-785_06904c03-cea9-4532-8e27-7f2246be613b
Urso 250
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115891478510100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
N020675
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": {
"e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61": {
"match": "brand_token",
"title": "URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [ALLERGAN, INC.]",
"spl_version": "19",
"published_date": "2025-07-08"
}
},
"productid": "58914-785_06904c03-cea9-4532-8e27-7f2246be613b",
"productndc": "58914-785",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020675",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "250MG",
"product_no": "001",
"approval_date": "Dec 10, 1997"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "500MG",
"product_no": "002",
"approval_date": "Jul 21, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "URSODIOL",
"shortage_reason": "Ursodiol Capsule",
"shortage_status": "current",
"proprietary_name": "Urso 250",
"active_ingred_unit": "mg/1",
"application_number": "NDA020675",
"marketing_category": "NDA",
"nonproprietary_name": "Ursodiol",
"start_marketing_date": "19971210",
"active_numerator_strength": "250"
}Related drugs
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Access this data programmatically
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