Medicine
Darunavir 800 mg tablet
Darunavir 800 mg tablet is a generic prescription medicine for oral use, made by 10 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 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Darunavir
- Brand
- Sold under the generic name
- Strength
- 800 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 500 tablets, 90 tablets and 13 more
- Manufacturers
- Viona PharmaceuticalsIndiaZydus LifesciencesIndiaDr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaCiplaIndiaNovadoz PharmaceuticalsIndiaBryant Ranch PrepackAmerican Health PackagingAmneal Pharmaceuticals NYExelan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AE10 Darunavir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 November 2023
- Identifiers
- RxCUI 670026, 1359269DailyMed set ID 92b286d5-1ee5-435b-9e1d-2e95c7f2ec69, 04a542b3-15ad-4a8a-aab4-ace8e08732f3, 5624cc30-d484-458e-b234-9bb745a118ca +8NDC 60219-1145, 72578-148, 69097-244 +8Application ANDA212493, ANDA214085, ANDA206288 +3
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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 31722-089-30 | Camber PharmaceuticalsIndia | 21 January 2025 |
| 30 tablet in 1 bottle | 69097-244-02 | CiplaIndia | 29 November 2023 |
| 500 tablet, film coated in 1 bottle | 43598-705-05 | Dr. Reddy's LaboratoriesIndia | 29 November 2023 |
| 30 tablet, film coated in 1 bottle | 43598-705-30 | Dr. Reddy's LaboratoriesIndia | 29 November 2023 |
| 30 tablet, film coated in 1 bottle, plastic | 72205-185-30 | Novadoz PharmaceuticalsIndia | 29 November 2023 |
| 500 tablet, film coated in 1 bottle | 72578-148-05 | Viona PharmaceuticalsIndia | 1 May 2024 |
| 30 tablet, film coated in 1 bottle | 72578-148-06 | Viona PharmaceuticalsIndia | 1 May 2024 |
| 90 tablet, film coated in 1 bottle | 72578-148-16 | Viona PharmaceuticalsIndia | 1 May 2024 |
| 30 tablet, film coated in 1 bottle | 70771-1746-3 | Zydus LifesciencesIndia | 1 May 2024 |
| 500 tablet, film coated in 1 bottle | 70771-1746-5 | Zydus LifesciencesIndia | 1 May 2024 |
| 90 tablet, film coated in 1 bottle | 70771-1746-9 | Zydus LifesciencesIndia | 1 May 2024 |
| 1 bottle, plastic in 1 carton / 30 tablet, film coated in 1 bottle, plastic | 60219-1145-3 | Amneal Pharmaceuticals NY | 9 December 2023 |
| 30 tablet in 1 bottle | 76282-738-30 | Exelan Pharmaceuticals | 19 January 2024 |
| 15 tablet in 1 bottle | 63629-5686-1 | Bryant Ranch Prepack | 5 June 2025 |
| 15 tablet, film coated in 1 bottle | 71335-2611-1 | Bryant Ranch Prepack | 11 March 2026 |
| 30 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-819-21 | American Health Packaging | 25 June 2024 |
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 Darunavir
Clinical summary
Darunavir 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 for oral use. MedsAcross supplies Darunavir 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 DarunavirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Darunavir prescribing information (Camber Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Prezista: European public assessment report (EPAR) · European Medicines Agency
- Darunavir Krka: European public assessment report (EPAR) · European Medicines Agency
Need Darunavir 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.