Medicine
Ursodiol 400 mg capsule
Ursodiol 400 mg capsule is a generic prescription medicine for oral use, made by 2 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 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F).
Key facts
- Active ingredient (INN)
- Ursodiol
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 100 capsules
- Manufacturers
- FH2 PharmaLGM Pharma Solutions
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F).
- 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
- 1 July 2020
- Identifiers
- RxCUI 412174, 2376942DailyMed set ID 476179dc-b410-4305-881b-470511765647, ebaaa3e2-1d80-4b40-b696-88cdd06448e4NDC 72887-144, 79739-7144Application ANDA205789
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 |
|---|---|---|---|
| 60 capsule in 1 bottle | 72887-144-06 | FH2 Pharma | 18 November 2021 |
| 100 capsule in 1 bottle | 79739-7144-1 | LGM Pharma Solutions | 1 July 2020 |
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 400 mg capsule.
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 400 mg capsule 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.