Medicine
Emtricitabine, Rilpivirine and Tenofovir disoproxil 200 mg/25 mg/300 mg tablet
Emtricitabine, Rilpivirine and Tenofovir disoproxil 200 mg/25 mg/300 mg tablet is a generic prescription medicine for oral use, made by 2 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).
Key facts
- Active ingredient (INN)
- Emtricitabine, Rilpivirine and Tenofovir disoproxil
- Brand
- Sold under the generic name
- Strength
- 200 mg/25 mg/300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Manufacturers
- Laurus LabsIndiaMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AR08 Emtricitabine, Rilpivirine and Tenofovir disoproxil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 May 2025
- Identifiers
- RxCUI 1147334DailyMed set ID d9a4185e-43fa-4aeb-9b0f-8db01b166038, 7193c90e-456c-4cfb-8181-65a1618dae51NDC 0378-5440, 42385-801Application ANDA208452, ANDA220232
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 | 42385-801-30 | Laurus LabsIndia | 5 March 2026 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-5440-93 | Mylan Pharmaceuticals | 27 May 2025 |
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 Emtricitabine, Rilpivirine and Tenofovir disoproxil 200 mg/25 mg/300 mg tablet.
Clinical summary
Emtricitabine, Rilpivirine and Tenofovir disoproxil is a fixed-dose combination of a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor, a hepatitis B virus nucleoside analog reverse transcriptase inhibitor and a human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor. MedsAcross supplies Emtricitabine, Rilpivirine and Tenofovir disoproxil 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 Emtricitabine, Rilpivirine and Tenofovir disoproxilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- COMPLERA prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
- Eviplera: European public assessment report (EPAR) · European Medicines Agency
Need Emtricitabine, Rilpivirine and Tenofovir disoproxil 200 mg/25 mg/300 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.