United States· US:81279-130_5e248968-a19d-4b59-9873-fba89f6b7fb1
URSOLIGN
A medicinal product containing ursodiol, registered in United States by Pangea Pharmaceuticals, LLC.
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
- Pangea Pharmaceuticals, LLC
- 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 · 1
- ndc1181279-130-60
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.
- ItalyDEURSILCHEPLAPHARM ARZNEIMITTEL GMBH
- SwitzerlandDe-ursil
- SpainURSOBILANE 150 mg CAPSULASLaboratorio Estedi S.L.
- PolandUrsopolBausch Health Ireland Ltd.
- United KingdomCholurso 250mg tabletsMayoly UK Ltd
- CzechiaUDIHEPNovatin Limited, Mgarr
- NetherlandsGrinterol 250 mg harde capsulesGrindeks AS
- FranceACIDE URSODESOXYCHOLIQUE ARROW 250 mg, comprimé pelliculéARROW GENERIQUES
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/0d62b79b-74f4-4a08-8ee2-79cdea38df90 GET /v1/drugs/0d62b79b-74f4-4a08-8ee2-79cdea38df90?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": "150",
"substance": "URSODIOL",
"productndc": "81279-130",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA210344",
"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.