🇺🇸
United States · US · US:79739-7144_efdeb26d-50b6-4a2f-886a-fcb59ea7fee0
Ursodiol 400 mg
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLGM PHARMA SOLUTIONS, LLC
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117973971441100 CAPSULE in 1 BOTTLE (79739-7144-1)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A205789
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": "79739-7144_efdeb26d-50b6-4a2f-886a-fcb59ea7fee0",
"productndc": "79739-7144",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205789",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "May 8, 2020"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "400MG",
"product_no": "002",
"approval_date": "May 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "URSODIOL",
"shortage_reason": "Ursodiol Capsule",
"shortage_status": "current",
"proprietary_name": "Ursodiol 400 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205789",
"marketing_category": "ANDA",
"nonproprietary_name": "Usodiol",
"start_marketing_date": "20200701",
"active_numerator_strength": "400"
}Related drugs
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