Medicine
Emtricitabine and Tenofovir disoproxil 200 mg/300 mg tablet
Emtricitabine and Tenofovir disoproxil 200 mg/300 mg tablet is a generic prescription medicine for oral use, made by 23 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 25 C (77 F), excursions permitted to 15º to 30 C (59 to 86 F).
Key facts
- Active ingredient (INN)
- Emtricitabine and Tenofovir disoproxil
- Brand
- Sold under the generic name
- Strength
- 200 mg/300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 10 blister pack, 90 tablets and 42 more
- Manufacturers
- Zydus LifesciencesIndiaCiplaIndiaLaurus LabsIndiaStrides PharmaIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaProficient RxBryant Ranch PrepackA-S Medication Solutions23 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25 C (77 F), excursions permitted to 15º 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
- J05AR03 Emtricitabine and Tenofovir disoproxil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 August 2018
- Identifiers
- RxCUI 476556, 1744001, 1744005 +1DailyMed set ID e4fb5710-e23b-429e-9b51-c12366e614fc, 31af598d-6ef2-469b-ac4c-3ac805e6fa44, 1289b02c-50f7-4adc-80d1-24afc1bad01b +29NDC 68180-287, 76282-677, 82804-086 +29Application ANDA204131, ANDA090958, ANDA201806 +7
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
A sample of 40 packs from 23 labelers. The register lists 45 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle, plastic | 69097-209-02 | CiplaIndia | 30 March 2021 |
| 30 tablet, film coated in 1 bottle, plastic | 69097-741-02 | CiplaIndia | 1 November 2021 |
| 30 tablet in 1 bottle, plastic | 42543-719-04 | Strides PharmaIndia | 30 March 2021 |
| 30 tablet in 1 bottle, plastic | 64380-719-04 | Strides PharmaIndia | 30 March 2021 |
| 30 tablet, film coated in 1 bottle | 70710-1367-3 | Zydus LifesciencesIndia | 24 March 2021 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70710-1367-4 | Zydus LifesciencesIndia | 24 March 2021 |
| 90 tablet, film coated in 1 bottle | 70710-1367-9 | Zydus LifesciencesIndia | 24 March 2021 |
| 30 tablet, film coated in 1 bottle | 70771-1709-3 | Zydus LifesciencesIndia | 24 March 2021 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70771-1709-4 | Zydus LifesciencesIndia | 24 March 2021 |
| 90 tablet, film coated in 1 bottle | 70771-1709-9 | Zydus LifesciencesIndia | 24 March 2021 |
| 30 tablet, film coated in 1 bottle | 65862-354-30 | Aurobindo PharmaIndia | 30 March 2021 |
| 30 tablet, film coated in 1 bottle | 31722-560-30 | Camber PharmaceuticalsIndia | 7 October 2021 |
| 30 tablet, film coated in 1 bottle | 42385-953-30 | Laurus LabsIndia | 26 July 2019 |
| 90 tablet, film coated in 1 bottle | 42385-953-90 | Laurus LabsIndia | 26 July 2019 |
| 30 tablet, film coated in 1 bottle | 33342-106-07 | Macleods PharmaceuticalsIndia | 15 May 2020 |
| 30 tablet, film coated in 1 bottle | 60219-2095-3 | Amneal Pharmaceuticals NY | 26 August 2018 |
| 30 tablet, film coated in 1 bottle | 69238-2095-3 | Amneal Pharmaceuticals NY | 26 August 2018 |
| 30 tablet, film coated in 1 bottle, plastic | 76282-677-30 | Exelan Pharmaceuticals | 6 April 2021 |
| 30 tablet, film coated in 1 bottle | 0093-7704-56 | Teva Pharmaceuticals | 20 January 2021 |
| 30 tablet, film coated in 1 bottle | 50090-6494-1 | A-S Medication Solutions | 22 May 2023 |
| 30 tablet, film coated in 1 bottle | 50090-7719-1 | A-S Medication Solutions | 16 October 2025 |
| 30 tablet, film coated in 1 bottle | 50090-8028-1 | A-S Medication Solutions | 3 August 2026 |
| 3 tablet, film coated in 1 bottle | 68071-3695-3 | NuCare Pharmaceuticals | 4 October 2024 |
| 3 tablet, film coated in 1 bottle | 68071-3831-3 | NuCare Pharmaceuticals | 18 April 2025 |
| 3 tablet, film coated in 1 bottle | 68071-3986-3 | NuCare Pharmaceuticals | 20 April 2026 |
| 3 tablet, film coated in 1 bottle | 71205-776-03 | Proficient Rx | 4 October 2024 |
| 7 tablet, film coated in 1 bottle | 71205-776-07 | Proficient Rx | 15 March 2023 |
| 30 tablet, film coated in 1 bottle | 71205-776-30 | Proficient Rx | 15 March 2023 |
| 60 tablet, film coated in 1 bottle | 71205-776-60 | Proficient Rx | 15 March 2023 |
| 90 tablet, film coated in 1 bottle | 71205-776-90 | Proficient Rx | 15 March 2023 |
| 3 tablet, film coated in 1 bottle | 82804-086-03 | Proficient Rx | 16 February 2026 |
| 7 tablet, film coated in 1 bottle | 82804-086-07 | Proficient Rx | 16 February 2026 |
| 30 tablet, film coated in 1 bottle | 42291-980-30 | AvKARE | 1 July 2025 |
| 30 tablet, film coated in 1 bottle | 71335-2650-1 | Bryant Ranch Prepack | 3 June 2025 |
| 3 tablet, film coated in 1 bottle | 71335-2650-2 | Bryant Ranch Prepack | 3 June 2025 |
| 15 tablet, film coated in 1 bottle | 71335-2650-3 | Bryant Ranch Prepack | 3 June 2025 |
| 6 tablet, film coated in 1 bottle | 71335-2650-4 | Bryant Ranch Prepack | 3 June 2025 |
| 3 tablet, film coated in 1 bottle | 72189-403-03 | Direct_Rx | 5 December 2022 |
| 3 tablet, film coated in 1 bottle | 72189-312-03 | DirectRx | 26 January 2022 |
| 30 tablet in 1 bottle, plastic | 51407-112-30 | Golden State Medical Supply | 9 April 2021 |
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 and Tenofovir disoproxil 200 mg/300 mg tablet.
Other strengths and forms of Emtricitabine and Tenofovir disoproxil
Clinical summary
Emtricitabine and Tenofovir disoproxil is a fixed-dose combination of a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor and a hepatitis B virus nucleoside analog reverse transcriptase inhibitor. MedsAcross supplies Emtricitabine 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 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
- Truvada prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
- Truvada: European public assessment report (EPAR) · European Medicines Agency
- Emtricitabine/Tenofovir disoproxil Krka d.d.: European public assessment report (EPAR) · European Medicines Agency
Need Emtricitabine and Tenofovir disoproxil 200 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.