🇺🇸
United States · US · US:64380-919_a9f0b231-1cf0-4695-b76c-111dfbe23d39
URSODIOL
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116438091906100 TABLET in 1 BOTTLE (64380-919-06)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A213504
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": "64380-919_a9f0b231-1cf0-4695-b76c-111dfbe23d39",
"productndc": "64380-919",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213504",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Aug 20, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Aug 20, 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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213504",
"marketing_category": "ANDA",
"nonproprietary_name": "ursodiol",
"start_marketing_date": "20210208",
"active_numerator_strength": "500"
}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
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