🇺🇸
United States · US · US:50268-797_48378beb-66aa-975e-e063-6294a90a0aee
Ursodiol
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502687971550 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A211301
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": "50268-797_48378beb-66aa-975e-e063-6294a90a0aee",
"productndc": "50268-797",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211301",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG",
"product_no": "001",
"approval_date": "Oct 16, 2018"
}
],
"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": "ANDA211301",
"marketing_category": "ANDA",
"nonproprietary_name": "Ursodiol",
"start_marketing_date": "20210219",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code A05AA02.
- FIAdursalTakeda Oy
- CAAG-URSODIOLANGITA PHARMA INC.
- PLAuroUrsoAurovitas Pharma Polska Sp. z o.o.
- IECholurso 250 mg film-coated tabletsLaboratoires Mayoly Spindler
- 🇫🇷CHOLURSO 250 mg, comprimé pelliculéLABORATOIRES MAYOLY SPINDLER
- GBCholurso 250mg tabletsMayoly UK Ltd
- IECholurso 500 mg film-coated tabletsLaboratoires Mayoly Spindler
- 🇫🇷CHOLURSO 500 mg, comprimé pelliculé sécableLABORATOIRES MAYOLY SPINDLER
Access this data programmatically
Query Ursodiol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.