Medicine
Ursodiol 300 mg capsule
Ursodiol 300 mg capsule is a generic prescription medicine for oral use, made by 18 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Ursodiol
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules, 500 capsules and 22 more
- Manufacturers
- Strides PharmaIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaLaurus LabsIndiaAvPAKBryant Ranch PrepackMajor PharmaceuticalsPuraCap LaboratoriesActavis PharmaAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 31 December 1987
- Identifiers
- RxCUI 858747DailyMed set ID bbb1f297-1536-9550-e053-2995a90a0d41, 4a161c84-141c-4741-8d69-31a6f3dfd18d, a061bb07-a85d-4b08-877f-ce02156f0de7 +19NDC 50268-797, 24658-999, 0591-3159 +19Application ANDA211301, ANDA075517, NDA019594 +7
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 capsule in 1 bottle | 70710-1483-1 | Zydus LifesciencesIndia | 21 January 2021 |
| 100 capsule in 1 bottle | 70771-1524-1 | Zydus LifesciencesIndia | 21 January 2021 |
| 100 capsule in 1 bottle | 59651-421-01 | Aurobindo PharmaIndia | 28 November 2022 |
| 100 capsule in 1 bottle | 42385-946-01 | Laurus LabsIndia | 17 April 2021 |
| 30 capsule in 1 bottle | 64380-844-04 | Strides PharmaIndia | 13 September 2021 |
| 100 capsule in 1 bottle | 64380-844-06 | Strides PharmaIndia | 13 September 2021 |
| 500 capsule in 1 bottle | 64380-844-07 | Strides PharmaIndia | 13 September 2021 |
| 100 capsule in 1 bottle | 24658-780-01 | PuraCap Laboratories | 15 December 2016 |
| 1000 capsule in 1 bottle | 24658-999-10 | PuraCap Laboratories | 30 September 2021 |
| 100 capsule in 1 bottle | 0591-3159-01 | Actavis Pharma | 31 December 1987 |
| 100 capsule in 1 bottle | 69238-1540-1 | Amneal Pharmaceuticals NY | 22 October 2018 |
| 60 capsule in 1 bottle | 62135-430-60 | Chartwell RX | 3 January 2023 |
| 100 capsule in 1 bottle | 42806-503-01 | Epic Pharma | 16 July 2010 |
| 100 capsule in 1 bottle | 0527-1326-01 | Lannett | 1 January 2009 |
| 100 capsule in 1 bottle, plastic | 72664-217-01 | VGYAAN Pharmaceuticals | 25 October 2020 |
| 50 blister pack in 1 box / 1 capsule in 1 blister pack | 50268-797-15 | AvPAK | 19 February 2021 |
| 30 blister pack in 1 box / 1 capsule in 1 blister pack | 50268-864-13 | AvPAK | 14 July 2026 |
| 100 capsule in 1 bottle | 72162-2168-1 | Bryant Ranch Prepack | 7 December 2023 |
| 100 capsule in 1 bottle | 72162-2619-1 | Bryant Ranch Prepack | 20 April 2026 |
| 100 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack | 60687-100-01 | American Health Packaging | 12 May 2015 |
| 100 capsule in 1 bottle | 42291-923-01 | AvKARE | 18 July 2023 |
| 100 capsule in 1 bottle | 51407-754-01 | Golden State Medical Supply | 5 May 2023 |
| 50 blister pack in 1 carton / 1 capsule in 1 blister pack | 0904-6221-06 | Major Pharmaceuticals | 1 April 2011 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 0904-6221-61 | Major Pharmaceuticals | 1 April 2011 |
| 100 capsule in 1 bottle | 72603-613-01 | NorthStar Rx | 1 May 2025 |
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
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 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.