Medicine
Ursodiol 500 mg tablet
Ursodiol 500 mg tablet is a generic prescription medicine for oral use, made by 7 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20 • C to 25 • C (68 • F to 77 • F). Due to the bitter taste, the…
Key facts
- Active ingredient (INN)
- Ursodiol
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 10 more
- Manufacturers
- Zydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaStrides PharmaIndiaBryant Ranch PrepackAvKAREBluePoint LaboratoriesPar Health
- Origin register
- US FDA, United States
- Storage
- Store at 20 • C to 25 • C (68 • F to 77 • F). Due to the bitter taste, the halved segments should be stored separately from the whole tablets
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A05AA02 Ursodiol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 July 2011
- Identifiers
- RxCUI 858733, 858751DailyMed set ID a3c98080-0a4d-4a93-8dcb-02ab8533050b, 9d666bbc-98c4-445f-a5a2-cad1bcccde4e, 5e6ced5f-b8ef-4e6b-a7c1-730bac650c5b +6NDC 68001-378, 64380-919, 63629-2287 +6Application ANDA090801, ANDA213504, ANDA202540 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 70710-1128-1 | Zydus LifesciencesIndia | 7 November 2018 |
| 500 tablet in 1 bottle | 70710-1128-5 | Zydus LifesciencesIndia | 7 November 2018 |
| 100 tablet in 1 bottle | 70771-1408-1 | Zydus LifesciencesIndia | 7 November 2018 |
| 500 tablet in 1 bottle | 70771-1408-5 | Zydus LifesciencesIndia | 7 November 2018 |
| 100 tablet in 1 bottle | 68462-474-01 | Glenmark PharmaceuticalsIndia | 12 July 2011 |
| 500 tablet in 1 bottle | 68462-474-05 | Glenmark PharmaceuticalsIndia | 12 July 2011 |
| 30 tablet in 1 bottle | 68462-474-30 | Glenmark PharmaceuticalsIndia | 12 July 2011 |
| 100 tablet in 1 bottle | 64380-919-06 | Strides PharmaIndia | 8 February 2021 |
| 100 tablet, film coated in 1 bottle | 49884-413-01 | Par Health | 1 August 2013 |
| 100 tablet, film coated in 1 bottle | 63629-2287-1 | Bryant Ranch Prepack | 29 March 2021 |
| 100 tablet, film coated in 1 bottle | 72162-1501-1 | Bryant Ranch Prepack | 30 March 2023 |
| 100 tablet, film coated in 1 bottle | 42291-931-01 | AvKARE | 14 December 2023 |
| 100 tablet in 1 bottle | 68001-378-00 | BluePoint Laboratories | 26 February 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 31 December 1987 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Ursodiol 500 mg tablet.
Other strengths and forms of Ursodiol
Clinical summary
Ursodiol is a bile acid indicated for patients with radiolucent, among other approved uses. MedsAcross supplies Ursodiol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about UrsodiolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ursodiol prescribing information (Actavis Pharma) · U.S. National Library of Medicine, DailyMed
Need Ursodiol 500 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.