Medicine
Darunavir ethanolate 600 mg tablet
Darunavir ethanolate 600 mg tablet is a generic prescription medicine for oral use, 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)
- Darunavir ethanolate
- Brand
- Sold under the generic name
- Strength
- 600 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets
- Manufacturer
- LupinIndia
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F).
- 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
- 1 June 2023
- Identifiers
- RxCUI 670026, 1359269DailyMed set ID 56daf67e-7501-4cd5-be22-566d7997d42eNDC 68180-345Application ANDA202073
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 | 68180-345-07 | LupinIndia | 1 June 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 | 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 600 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 Darunavir ethanolate 600 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.