🇺🇸
United States · US · US:0904-6221_7aace946-7c2a-422f-a905-c6afe5f8327f
Ursodiol
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11090462210650 BLISTER PACK in 1 CARTON (0904-6221-06) / 1 CAPSULE in 1 BLISTER PACK
- ndc110904622161100 BLISTER PACK in 1 CARTON (0904-6221-61) / 1 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A075517
AB
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": "0904-6221_7aace946-7c2a-422f-a905-c6afe5f8327f",
"productndc": "0904-6221",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075517",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Mar 14, 2000"
}
],
"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": "ANDA075517",
"marketing_category": "ANDA",
"nonproprietary_name": "Ursodiol",
"start_marketing_date": "20110401",
"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
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