Medicine
Prezista 800 mg tablet
Prezista 800 mg tablet is a prescription medicine containing Darunavir ethanolate for oral use, marketed by Janssen Products, 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
Do not refrigerate or freeze. Store at 25°C (77°F), with excursions permitted…
Key facts
- Active ingredient (INN)
- Darunavir ethanolate
- Brand
- Prezista
- Strength
- 800 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Janssen Products
- Manufacturer
- Janssen Products
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate or freeze. Store at 25°C (77°F), with excursions permitted to 15°–30°C (59°–86°F). PREZISTA Tablets Store at 25°C (77°F), with excursions permitted to 15°–30°C (59°–86°F). Store in the original container.
- 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
- 9 November 2012
- Identifiers
- RxCUI 670026, 794610, 831868 +7DailyMed set ID 814301f9-c990-46a5-b481-2879a521a16fNDC 59676-566Application NDA021976
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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle, plastic | 59676-566-30 | Janssen Products | 9 November 2012 |
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 | Approved | 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 Darunavir ethanolate 800 mg tablet.
Other strengths and forms of Darunavir ethanolate
Clinical summary
Darunavir ethanolate is a protease inhibitor indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older. It is available as tablets and oral suspension. MedsAcross supplies Darunavir ethanolate 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 Darunavir ethanolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PREZISTA prescribing information (Janssen Products) · U.S. National Library of Medicine, DailyMed
Need Prezista 800 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.