United States· US:68462-474_71c17751-51cb-411d-b90b-4b98ad4a768e
Ursodiol
A medicinal product containing ursodiol, registered in United States by Glenmark Pharmaceuticals Inc., USA.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- URSODIOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc116846247401100 TABLET in 1 BOTTLE (68462-474-01)
- ndc116846247405500 TABLET in 1 BOTTLE (68462-474-05)
- ndc11684624743030 TABLET in 1 BOTTLE (68462-474-30)
- ndc1168462-474-01
- ndc1168462-474-05
- ndc1168462-474-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ursodiol in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomCholurso 500mg tabletsMayoly UK Ltd
- CanadaGLN-URSODIOLGLENMARK PHARMACEUTICALS CANADA INC.
- NetherlandsUrsodeoxycholzuur Teva 500 mg, tablettenTeva B.V.
- CzechiaUDIHEPNovatin Limited, Mgarr
- ItalyACIDO URSODESOSSICOLICORATIOPHARM GMBH
- FranceACIDE URSODESOXYCHOLIQUE ARROW 250 mg, comprimé pelliculéARROW GENERIQUES
- SwitzerlandDe-ursil
- BelgiumDozurso 250 mgLaboratoires Mayoly Spindler
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Ursodeoxycholsäure Pharmaceutical Innovation, Ursofalk
- Belgium · Dozurso, Ursochol
- Bulgaria · Proursan, Udca 250 Mg
- Cyprus · Ursobil, Ursofalk
- Czechia · Udihep, Ursofalk
- Germany · Urso, Ursochol
- Denmark · Ursedeoxycholsyre Orion, Ursochol
- Estonia · Ursogrix, Ursosan
- Spain · Adisocol, Colefel
- Finland · Ursochol, Ursosan
- France · Acide Ursodesoxycholique Arrow, Acide Ursodesoxycholique Biogaran
- United Kingdom (Northern Ireland) · Cholurso, Deoxxa
- Greece · Ursodeoxycholic Acid Pharmaceutical Innovation, Ursofalk
- Croatia · Udihep, Ursofalk
- Hungary · Dozurso, Proursan
- Ireland · Cholurso, Proursan
- Iceland · Ursochol
- Italy · Acido Ursodesossicolico Abc, Acido Ursodesossicolico Aurobindo
- Lithuania · Ursofalk, Ursogrix
- Luxembourg · Ursochol, Ursodeoxycholic Acid Amdipharm
- Latvia · Ursofalk, Ursogrix
- Malta · Ursobil, Ursodeoxycholic Acid Aurobindo
- Netherlands · Grinterol, Ursochol
- Norway · Ursochol, Ursodeoxycholic Acid Orion
- Poland · Aurourso, Kwas Ursodeoksycholowy Pharmaceutical Innovation
- Portugal · Ácido Ursodesoxicólico Generis, Grinterol
- Romania · Ursofalk, Ursogrix
- Sweden · Ursodeoxycholic Acid Orion, Ursofalk
- Slovenia · Ursofalk
- Slovakia · Ursofalk, Ursogrix
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/f8f7c486-cb01-4396-82e5-4d5c0ea3be48 GET /v1/drugs/f8f7c486-cb01-4396-82e5-4d5c0ea3be48?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "500",
"substance": "URSODIOL",
"productndc": "68462-474",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA090801",
"marketing_category": "ANDA"
}See everything about ursodiol.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.