Medicine
Isentress 400 mg tablet
Isentress 400 mg tablet is a prescription medicine containing Raltegravir for oral use, marketed by Merck Sharp & Dohme, 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 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). See USP…
Key facts
- Active ingredient (INN)
- Raltegravir
- Brand
- Isentress
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets, 6 tablets, 14 tablets and 5 more
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturers
- Merck Sharp & DohmeProficient RxA-S Medication SolutionsNuCare Pharmaceuticals,Inc
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. 400 mg Film-coated Tablets Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AJ01 Raltegravir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 October 2007
- Identifiers
- RxCUI 744842, 744846, 1235588 +7DailyMed set ID ccc6f2f9-696f-4ef9-bb4c-e0198d957b0b, 89a5ec53-d956-4329-8004-0f40f51c88a3, 7e659505-c902-4906-9461-1cc83e2236d2 +1NDC 71205-777, 0006-0227, 50090-1085 +1Application NDA022145
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 |
|---|---|---|---|
| 60 tablet, film coated in 1 bottle | 0006-0227-61 | Merck Sharp & Dohme | 12 October 2007 |
| 60 tablet, film coated in 1 bottle | 50090-1085-0 | A-S Medication Solutions | 28 November 2014 |
| 6 tablet, film coated in 1 bottle | 68071-2113-6 | NuCare Pharmaceuticals,Inc | 25 January 2017 |
| 6 tablet, film coated in 1 bottle | 71205-777-06 | Proficient Rx | 3 October 2024 |
| 14 tablet, film coated in 1 bottle | 71205-777-14 | Proficient Rx | 15 March 2023 |
| 30 tablet, film coated in 1 bottle | 71205-777-30 | Proficient Rx | 15 March 2023 |
| 60 tablet, film coated in 1 bottle | 71205-777-60 | Proficient Rx | 15 March 2023 |
| 90 tablet, film coated in 1 bottle | 71205-777-90 | Proficient Rx | 15 March 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.
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 Raltegravir 400 mg tablet.
Other strengths and forms of Raltegravir
Clinical summary
Raltegravir is a human immunodeficiency virus integrase strand transfer inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients, among other approved uses. MedsAcross supplies Raltegravir 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 RaltegravirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ISENTRESS prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Isentress: European public assessment report (EPAR) · European Medicines Agency
Need Isentress 400 mg tablet 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.