Medicine
Lubiprostone 8 mcg capsule
Lubiprostone 8 mcg capsule is a generic prescription medicine for oral use, made by 15 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° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Lubiprostone
- Brand
- Sold under the generic name
- Strength
- 8 mcg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 60 capsules, 40 blister pack and 32 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaNatco PharmaIndiaSun Pharmaceutical IndustriesIndiaProficient RxAsclemedAmneal PharmaceuticalsAdvanced Rx of TennesseeAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and extreme temperatures.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A06AX03 Lubiprostone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 April 2008
- Identifiers
- RxCUI 794639, 616578DailyMed set ID 031170a4-5f7d-b371-e063-6394a90ae21d, 10c7b62d-6c39-453c-8d9a-2f441725bc3b, 333acede-5075-464f-9418-4b22d43eef3c +14NDC 80425-0354, 69339-162, 65162-841 +14Application NDA021908, ANDA209450, ANDA214131 +2
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 | 70710-1641-1 | Zydus LifesciencesIndia | 23 March 2023 |
| 60 capsule in 1 bottle | 70710-1641-6 | Zydus LifesciencesIndia | 23 March 2023 |
| 100 capsule in 1 bottle | 70771-1763-1 | Zydus LifesciencesIndia | 23 March 2023 |
| 60 capsule in 1 bottle | 70771-1763-6 | Zydus LifesciencesIndia | 23 March 2023 |
| 60 capsule in 1 bottle | 31722-403-60 | Camber PharmaceuticalsIndia | 27 May 2025 |
| 60 capsule, gelatin coated in 1 bottle | 43598-163-60 | Dr. Reddy's LaboratoriesIndia | 1 January 2023 |
| 40 blister pack in 1 carton / 1 capsule, gelatin coated in 1 blister pack | 69339-162-17 | Natco PharmaIndia | 17 October 2022 |
| 60 capsule, gelatin coated in 1 bottle | 63304-351-60 | Sun Pharmaceutical IndustriesIndia | 1 January 2023 |
| 60 capsule in 1 bottle | 65162-841-06 | Amneal Pharmaceuticals | 3 December 2021 |
| 180 capsule in 1 bottle | 65162-841-18 | Amneal Pharmaceuticals | 3 December 2021 |
| 60 capsule, gelatin coated in 1 bottle | 0254-3028-02 | Par Health | 1 January 2021 |
| 60 capsule, gelatin coated in 1 bottle | 0406-6408-60 | SpecGx | 1 May 2024 |
| 60 capsule, gelatin coated in 1 bottle | 0480-3479-06 | Teva Pharmaceuticals | 3 January 2023 |
| 100 capsule in 1 bottle | 76420-777-01 | Asclemed | 7 February 2025 |
| 30 capsule in 1 bottle | 76420-777-30 | Asclemed | 7 February 2025 |
| 60 capsule in 1 bottle | 76420-777-60 | Asclemed | 7 February 2025 |
| 90 capsule in 1 bottle | 76420-777-90 | Asclemed | 7 February 2025 |
| 100 capsule, gelatin coated in 1 bottle | 76420-906-01 | Asclemed | 28 January 2025 |
| 30 capsule, gelatin coated in 1 bottle | 76420-906-30 | Asclemed | 28 January 2025 |
| 60 capsule, gelatin coated in 1 bottle | 76420-906-60 | Asclemed | 28 January 2025 |
| 90 capsule, gelatin coated in 1 bottle | 76420-906-90 | Asclemed | 28 January 2025 |
| 60 capsule, gelatin coated in 1 bottle | 80425-0354-2 | Advanced Rx of Tennessee | 16 August 2023 |
| 20 blister pack in 1 carton / 1 capsule, gelatin coated in 1 blister pack | 60687-816-32 | American Health Packaging | 18 March 2026 |
| 60 capsule, gelatin coated in 1 bottle | 51407-744-60 | Golden State Medical Supply | 23 January 2023 |
| 60 capsule in 1 bottle | 72603-288-01 | Northstar Rx | 1 July 2025 |
| 100 capsule, gelatin coated in 1 bottle | 71205-831-00 | Proficient Rx | 18 October 2023 |
| 1000 capsule, gelatin coated in 1 bottle | 71205-831-11 | Proficient Rx | 18 October 2023 |
| 30 capsule, gelatin coated in 1 bottle | 71205-831-30 | Proficient Rx | 18 October 2023 |
| 500 capsule, gelatin coated in 1 bottle | 71205-831-55 | Proficient Rx | 18 October 2023 |
| 60 capsule, gelatin coated in 1 bottle | 71205-831-60 | Proficient Rx | 18 October 2023 |
| 240 capsule, gelatin coated in 1 bottle | 71205-831-64 | Proficient Rx | 18 October 2023 |
| 270 capsule, gelatin coated in 1 bottle | 71205-831-67 | Proficient Rx | 18 October 2023 |
| 120 capsule, gelatin coated in 1 bottle | 71205-831-72 | Proficient Rx | 18 October 2023 |
| 180 capsule, gelatin coated in 1 bottle | 71205-831-78 | Proficient Rx | 18 October 2023 |
| 90 capsule, gelatin coated in 1 bottle | 71205-831-90 | Proficient Rx | 18 October 2023 |
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 January 2006 | 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 Lubiprostone 8 mcg capsule.
Other strengths and forms of Lubiprostone
Clinical summary
Lubiprostone is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) in adults, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Lubiprostone 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 LubiprostoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lubiprostone prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Lubiprostone 8 mcg 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.