United States· US:64380-918_a9f0b231-1cf0-4695-b76c-111dfbe23d39
URSODIOL
A ursodeoxycholic acid product containing ursodiol, registered in United States by Strides Pharma Science Limited. The same ATC class is registered in 16 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Ursodeoxycholic acid is registered in 16 of 19 countries.
Countries holding a registration under ATC A05AA02 (ursodeoxycholic acid), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 9 of them publish a price we can compare per daily dose
Ursodeoxycholic acid · ATC A05AA02
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of ursodeoxycholic acid costs, country by country.
Normalised to the WHO defined daily dose (0.75 g), the median price runs from $0.77 in Italy to $3.43 in Switzerland — a ×4.4 gap.
- United States: $1.16 per daily dose (median across products in the class)
- Public list prices, converted to USD at the rate date shown
- US figures are pharmacy acquisition cost (CMS NADAC), not retail
Ursodeoxycholic acid · price per daily dose (0.75 g)
USD · FX 28 Sept 2026
- CH Switzerland$3.43
- US United States$1.16 (acquisition cost)
- IT Italy$0.77
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ursodiol
- Manufacturer
- Strides Pharma Science Limited
- Country
- United States (US)
- ATC code
- A05AA02
- ATC class
- Ursodeoxycholic acid
- Defined daily dose
- 0.75 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 1
- ndc116438091806100 TABLET in 1 BOTTLE (64380-918-06)
Regulatory notes
Interactions
331 interactions on record for ursodeoxycholic acid.
Graded by severity as the source publishes them — 2 minor. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Ursodeoxycholic acid · interactions on record
331 records
Same medicine, other countries
Ursodeoxycholic acid in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaAG-URSODIOLANGITA PHARMA INC.
- United KingdomCholurso 250mg tabletsMayoly UK Ltd
- PolandUrsocamPolfarmex S.A.
- CzechiaUDIHEPNovatin Limited, Mgarr
- ItalyACIDO URSODESOSSICOLICORATIOPHARM GMBH
- NetherlandsGrinterol 250 mg harde capsulesGrindeks AS
- FranceACIDE URSODESOXYCHOLIQUE ARROW 250 mg, comprimé pelliculéARROW GENERIQUES
- SwitzerlandDe-ursil
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/d8c07cbc-0bde-4f62-aec8-a31831d4a7b9 GET /v1/drugs/d8c07cbc-0bde-4f62-aec8-a31831d4a7b9?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.
{
"unii": {
"unii": "724L30Y2QR",
"rxcui": "11065",
"inchikey": "RUDATBOHQWOJDD-UZVSRGJWSA-N",
"display_name": "URSODIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 4
},
"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": "64380-918_a9f0b231-1cf0-4695-b76c-111dfbe23d39",
"productndc": "64380-918",
"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": "250"
}See everything about ursodeoxycholic acid.
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.