Medicine
Ursodiol 300 mg capsule
Ursodiol 300 mg capsule is a prescription medicine containing Ursadiol for oral use, marketed by KVK-Tech, 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 to 25°C (68 to 77°F), excursions permitted within 15 o to 30 • C…
Key facts
- Active ingredient (INN)
- Ursadiol
- Brand
- Ursodiol
- Strength
- 300 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 60 capsules, 180 capsules and 1 more
- Marketing authorisation holder
- KVK-Tech
- Manufacturers
- KVK-TechPD-Rx Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 to 25°C (68 to 77°F), excursions permitted within 15 o to 30 • C (59 o to 86 • F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 May 2018
- Identifiers
- RxCUI 858747DailyMed set ID d89c9e1e-a115-4a01-9275-74d6cd8cf285, fff2640b-b704-4303-acae-8647fce58a08NDC 43063-871, 10702-237Application ANDA210707
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 10702-237-01 | KVK-Tech | 17 May 2018 |
| 100 capsule in 1 bottle, plastic | 43063-871-01 | PD-Rx Pharmaceuticals | 26 July 2018 |
| 60 capsule in 1 bottle, plastic | 43063-871-60 | PD-Rx Pharmaceuticals | 10 December 2019 |
| 180 capsule in 1 bottle, plastic | 43063-871-93 | PD-Rx Pharmaceuticals | 10 December 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 |
| 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
Clinical summary
Ursadiol is a prescription medicine indicated for patients with radiolucent, among other approved uses. MedsAcross supplies Ursadiol 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 UrsadiolFor 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 (KVK-Tech) · U.S. National Library of Medicine, DailyMed
Need Ursodiol 300 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.