Medicine
Entecavir 0.5 mg tablet
Entecavir 0.5 mg tablet is a generic prescription medicine for oral use, made by 14 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 in the outer carton to protect from light.
Key facts
- Active ingredient (INN)
- Entecavir
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 90 tablets and 28 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaAurobindo PharmaIndiaCiplaIndiaSolco HealthcareEpic PharmaYaopharmaAmerican Health PackagingAmneal PharmaceuticalsAvKARE
- Origin register
- US FDA, United States
- Storage
- Store in the outer carton to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AF10 Entecavir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 November 2014
- Identifiers
- RxCUI 485434, 485436DailyMed set ID d69451df-e204-4a5c-a2bb-9e6d4d519302, 01ec50a1-6c6c-46f0-8c74-73542b0a59c3, a0d2e00d-21f0-4449-93b7-a19fa284d51d +13NDC 42806-667, 31722-833, 60687-216 +13Application ANDA216857, ANDA205740, ANDA206217 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 68382-920-01 | Zydus LifesciencesIndia | 10 August 2017 |
| 30 tablet, film coated in 1 bottle | 68382-920-06 | Zydus LifesciencesIndia | 10 August 2017 |
| 90 tablet, film coated in 1 bottle | 68382-920-16 | Zydus LifesciencesIndia | 10 August 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 68382-920-77 | Zydus LifesciencesIndia | 10 August 2017 |
| 100 tablet, film coated in 1 bottle | 70771-1019-1 | Zydus LifesciencesIndia | 10 August 2017 |
| 30 tablet, film coated in 1 bottle | 70771-1019-3 | Zydus LifesciencesIndia | 10 August 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70771-1019-4 | Zydus LifesciencesIndia | 10 August 2017 |
| 90 tablet, film coated in 1 bottle | 70771-1019-9 | Zydus LifesciencesIndia | 10 August 2017 |
| 1 bottle in 1 carton / 30 tablet in 1 bottle | 65862-841-30 | Aurobindo PharmaIndia | 26 August 2015 |
| 1 bottle in 1 carton / 90 tablet in 1 bottle | 65862-841-90 | Aurobindo PharmaIndia | 26 August 2015 |
| 1 bottle in 1 carton / 1000 tablet in 1 bottle | 65862-841-99 | Aurobindo PharmaIndia | 26 August 2015 |
| 30 tablet in 1 bottle | 31722-833-30 | Camber PharmaceuticalsIndia | 21 August 2015 |
| 10 tablet in 1 blister pack | 31722-833-31 | Camber PharmaceuticalsIndia | 21 August 2015 |
| 100 tablet in 1 carton | 31722-833-32 | Camber PharmaceuticalsIndia | 21 August 2015 |
| 90 tablet in 1 bottle | 31722-833-90 | Camber PharmaceuticalsIndia | 21 August 2015 |
| 30 tablet, film coated in 1 bottle, plastic | 69097-426-02 | CiplaIndia | 6 December 2016 |
| 90 tablet, film coated in 1 bottle, plastic | 69097-426-05 | CiplaIndia | 6 December 2016 |
| 30 tablet in 1 bottle, plastic | 42806-658-30 | Epic Pharma | 2 June 2020 |
| 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 42806-667-30 | Epic Pharma | 1 November 2022 |
| 30 tablet, film coated in 1 bottle | 65162-446-03 | Amneal Pharmaceuticals | 28 November 2014 |
| 30 tablet in 1 bottle | 42494-457-30 | Cameron Pharmaceuticals | 15 May 2025 |
| 30 tablet in 1 bottle, plastic | 61442-311-30 | Carlsbad Technology | 10 November 2021 |
| 30 tablet, film coated in 1 bottle | 43547-436-03 | Solco Healthcare | 1 April 2018 |
| 90 tablet, film coated in 1 bottle | 43547-436-09 | Solco Healthcare | 1 April 2018 |
| 500 tablet, film coated in 1 bottle | 43547-436-50 | Solco Healthcare | 1 April 2018 |
| 30 tablet, film coated in 1 bottle | 50771-013-01 | Yaopharma | 1 July 2023 |
| 90 tablet, film coated in 1 bottle | 50771-013-02 | Yaopharma | 1 July 2023 |
| 30 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 60687-216-25 | American Health Packaging | 12 August 2016 |
| 30 tablet, film coated in 1 bottle | 42291-261-30 | AvKARE | 2 November 2020 |
| 30 tablet in 1 bottle, plastic | 51407-589-30 | Golden State Medical Supply | 26 August 2024 |
| 30 tablet, film coated in 1 bottle, plastic | 16714-717-01 | NorthStar RxLLC | 15 June 2017 |
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 Entecavir 0.5 mg tablet.
Other strengths and forms of Entecavir
Clinical summary
Entecavir is a hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults, among other approved uses. It is available as tablets and oral solution. MedsAcross supplies Entecavir 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 EntecavirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BARACLUDE prescribing information (ER Squibb & Sons) · U.S. National Library of Medicine, DailyMed
- Baraclude: European public assessment report (EPAR) · European Medicines Agency
- Entecavir Accord: European public assessment report (EPAR) · European Medicines Agency
Need Entecavir 0.5 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.