Medicine
Efavirenz, Lamivudine and Tenofovir disoproxil 400 mg/300 mg/300 mg tablet
Efavirenz, Lamivudine and Tenofovir disoproxil 400 mg/300 mg/300 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 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Efavirenz, Lamivudine and Tenofovir disoproxil
- Brand
- Sold under the generic name
- Strength
- 400 mg/300 mg/300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 180 tablets, 30 tablets, 90 tablets and 3 more
- Manufacturer
- Laurus LabsIndia
- 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 May 2020
- Identifiers
- RxCUI 2001424DailyMed set ID 98342153-b9de-4318-aac4-9f8d19590cd7NDC 42385-929Application ANDA213038
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 |
|---|---|---|---|
| 180 tablet, film coated in 1 bottle | 42385-929-18 | Laurus LabsIndia | 14 May 2020 |
| 30 tablet, film coated in 1 bottle | 42385-929-30 | Laurus LabsIndia | 14 May 2020 |
| 30 tablet, film coated in 1 bottle | 42385-929-31 | Laurus LabsIndia | 14 May 2020 |
| 180 tablet, film coated in 1 bottle | 42385-929-82 | Laurus LabsIndia | 14 May 2020 |
| 90 tablet, film coated in 1 bottle | 42385-929-90 | Laurus LabsIndia | 14 May 2020 |
| 90 tablet, film coated in 1 bottle | 42385-929-91 | Laurus LabsIndia | 14 May 2020 |
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 | First approved 5 February 2018 | 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
Other strengths and forms of Efavirenz, Lamivudine and Tenofovir disoproxil
Clinical summary
Efavirenz, Lamivudine and Tenofovir disoproxil is a fixed-dose combination of a hepatitis B virus nucleoside analog reverse transcriptase inhibitor, a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor and a human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor. MedsAcross supplies Efavirenz, Lamivudine 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 Efavirenz, Lamivudine 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
- SYMFI prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Efavirenz, Lamivudine and Tenofovir disoproxil 400 mg/300 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.