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.

In shortageATC A05AA02Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedURSODIOLATCA05AA02REGISTER NO.US:64380-918_a9f0b231…PACKS LISTED1CHECKEDSeptember 12, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

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

  • ndc11
    6438091806
    100 TABLET in 1 BOTTLE (64380-918-06)

Regulatory notes

UNII (FDA substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A213504
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ursodiol Capsule

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

  • 2 minor
  • 329 info

Most severe, free to view

    Mechanism and what to do, in the interaction check
    Interaction register. Grades as the source publishes them.

    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.

    All ursodeoxycholic acid products

    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.