🇺🇸
United States · US · US:68462-474_71c17751-51cb-411d-b90b-4b98ad4a768e
Ursodiol
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116846247401100 TABLET in 1 BOTTLE (68462-474-01)
- ndc116846247405500 TABLET in 1 BOTTLE (68462-474-05)
- ndc11684624743030 TABLET in 1 BOTTLE (68462-474-30)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A090801
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": "68462-474_71c17751-51cb-411d-b90b-4b98ad4a768e",
"productndc": "68462-474",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090801",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jul 12, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jul 12, 2011"
}
],
"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": "ANDA090801",
"marketing_category": "ANDA",
"nonproprietary_name": "Ursodiol",
"start_marketing_date": "20110712",
"active_numerator_strength": "500"
}Related drugs
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- IECholurso 250 mg film-coated tabletsLaboratoires Mayoly Spindler
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- 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
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