Medicine
Vascepa 500 mg capsule
Vascepa 500 mg capsule is a prescription medicine containing Icosapent ethyl for oral use, marketed by Amarin Pharma, 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), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Icosapent ethyl
- Brand
- Vascepa
- Strength
- 500 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 blister pack, 240 capsules
- Marketing authorisation holder
- Amarin Pharma
- Manufacturer
- Amarin Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AX Cholesterol and lipid-lowering medicines, subgroup C10A, subgroup C10AX
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 September 2016
- Identifiers
- RxCUI 1304979, 1304985, 1811180 +1DailyMed set ID 9c1a2828-1583-4414-ab22-a60480e8e508NDC 52937-003Application NDA202057
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 |
|---|---|---|---|
| 1 blister pack in 1 carton / 16 capsule in 1 blister pack | 52937-003-16 | Amarin Pharma | 16 September 2016 |
| 240 capsule in 1 bottle | 52937-003-40 | Amarin Pharma | 16 September 2016 |
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.
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 Icosapent ethyl
Clinical summary
Icosapent ethyl is a prescription medicine indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Icosapent ethyl 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 Icosapent ethylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Vascepa prescribing information (Amarin Pharma) · U.S. National Library of Medicine, DailyMed
- Vazkepa: European public assessment report (EPAR) · European Medicines Agency
Need Vascepa 500 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.