Medicine
Eszopiclone 3 mg tablet
Eszopiclone 3 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Eszopiclone
- Brand
- Sold under the generic name
- Strength
- 3 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 66 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaLupinIndiaAsclemedAdvanced Rx of TennesseeA-S Medication Solutions23 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05CF04 Eszopiclone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 March 2013
- Identifiers
- RxCUI 485440, 485442, 485465DailyMed set ID 8bb1965e-7845-4c5b-b021-38e251303d68, f18cc76f-82aa-4ad7-b8ce-5737733ee104, 9a891ab1-675f-498e-a21e-05964307d2dd +26NDC 47335-588, 65862-969, 71335-0116 +26Application ANDA091103, ANDA208451, ANDA202929 +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 52 packs from 23 labelers. The register lists 69 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-969-01 | Aurobindo PharmaIndia | 15 September 2016 |
| 30 tablet, film coated in 1 bottle | 65862-969-30 | Aurobindo PharmaIndia | 15 September 2016 |
| 100 tablet, film coated in 1 bottle | 31722-857-01 | Camber PharmaceuticalsIndia | 4 January 2024 |
| 30 tablet, film coated in 1 bottle | 31722-857-30 | Camber PharmaceuticalsIndia | 4 January 2024 |
| 100 tablet, coated in 1 bottle | 55111-617-01 | Dr. Reddy's LaboratoriesIndia | 15 April 2014 |
| 500 tablet, coated in 1 bottle | 55111-617-05 | Dr. Reddy's LaboratoriesIndia | 15 April 2014 |
| 9 blister pack in 1 carton / 10 tablet, coated in 1 blister pack | 55111-617-09 | Dr. Reddy's LaboratoriesIndia | 15 April 2014 |
| 30 tablet, coated in 1 bottle | 55111-617-30 | Dr. Reddy's LaboratoriesIndia | 15 April 2014 |
| 90 tablet, coated in 1 bottle | 55111-617-90 | Dr. Reddy's LaboratoriesIndia | 15 April 2014 |
| 100 tablet, film coated in 1 bottle | 68462-384-01 | Glenmark PharmaceuticalsIndia | 15 April 2014 |
| 1000 tablet, film coated in 1 bottle | 68462-384-10 | Glenmark PharmaceuticalsIndia | 15 April 2014 |
| 30 tablet, film coated in 1 bottle | 68462-384-30 | Glenmark PharmaceuticalsIndia | 15 April 2014 |
| 100 tablet, film coated in 1 bottle | 68180-324-01 | LupinIndia | 15 April 2014 |
| 100 tablet, film coated in 1 bottle | 33342-301-11 | Macleods PharmaceuticalsIndia | 31 January 2015 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-301-12 | Macleods PharmaceuticalsIndia | 31 January 2015 |
| 1000 tablet, film coated in 1 bottle | 33342-301-44 | Macleods PharmaceuticalsIndia | 31 January 2015 |
| 100 tablet, film coated in 1 bottle | 47335-588-08 | Sun Pharmaceutical IndustriesIndia | 15 April 2014 |
| 1000 tablet, film coated in 1 bottle | 47335-588-18 | Sun Pharmaceutical IndustriesIndia | 15 April 2014 |
| 30 tablet, film coated in 1 bottle | 47335-588-83 | Sun Pharmaceutical IndustriesIndia | 15 April 2014 |
| 100 tablet, film coated in 1 bottle | 47335-588-88 | Sun Pharmaceutical IndustriesIndia | 15 April 2014 |
| 100 tablet, film coated in 1 bottle, plastic | 69452-349-20 | Bionpharma | 1 June 2022 |
| 100 tablet, film coated in 1 bottle, plastic | 0378-5272-01 | Mylan Pharmaceuticals | 26 March 2013 |
| 100 tablet, film coated in 1 bottle | 0093-5539-01 | Teva Pharmaceuticals | 14 April 2014 |
| 30 tablet, film coated in 1 bottle | 80425-0065-1 | Advanced Rx of Tennessee | 25 April 2014 |
| 30 tablet, film coated in 1 bottle | 80425-0066-1 | Advanced Rx of Tennessee | 15 September 2016 |
| 30 tablet, coated in 1 bottle | 80425-0067-1 | Advanced Rx of Tennessee | 15 April 2014 |
| 30 tablet, film coated in 1 bottle | 50090-3514-0 | A-S Medication Solutions | 26 July 2018 |
| 30 tablet, film coated in 1 bottle | 50090-7746-0 | A-S Medication Solutions | 31 October 2025 |
| 100 tablet, film coated in 1 bottle | 76420-027-01 | Asclemed | 17 June 2020 |
| 10 tablet, film coated in 1 bottle | 76420-027-10 | Asclemed | 17 June 2020 |
| 20 tablet, film coated in 1 bottle | 76420-027-20 | Asclemed | 17 June 2020 |
| 30 tablet, film coated in 1 bottle | 76420-027-30 | Asclemed | 17 June 2020 |
| 60 tablet, film coated in 1 bottle | 76420-027-60 | Asclemed | 17 June 2020 |
| 90 tablet, film coated in 1 bottle | 76420-027-90 | Asclemed | 17 June 2020 |
| 1000 tablet, film coated in 1 bottle | 76420-354-00 | Asclemed | 22 May 2025 |
| 100 tablet, film coated in 1 bottle | 76420-354-01 | Asclemed | 22 May 2025 |
| 30 tablet, film coated in 1 bottle | 76420-354-30 | Asclemed | 22 May 2025 |
| 60 tablet, film coated in 1 bottle | 76420-354-60 | Asclemed | 22 May 2025 |
| 90 tablet, film coated in 1 bottle | 76420-354-90 | Asclemed | 22 May 2025 |
| 30 tablet, film coated in 1 bottle, plastic | 43063-795-30 | PD-Rx Pharmaceuticals | 9 October 2017 |
| 30 tablet, film coated in 1 bottle | 71335-2002-1 | — | 10 February 2022 |
| 60 tablet, film coated in 1 bottle | 71335-2002-2 | — | 10 February 2022 |
| 90 tablet, film coated in 1 bottle | 71335-2002-3 | — | 10 February 2022 |
| 120 tablet, film coated in 1 bottle | 71335-2002-4 | — | 10 February 2022 |
| 20 tablet, film coated in 1 bottle | 71335-2002-5 | — | 10 February 2022 |
| 28 tablet, film coated in 1 bottle | 71335-2002-6 | — | 10 February 2022 |
| 15 tablet, film coated in 1 bottle | 71335-2002-7 | — | 10 February 2022 |
| 100 tablet, film coated in 1 bottle | 71335-2002-8 | — | 10 February 2022 |
| 30 tablet, film coated in 1 bottle | 68071-2403-3 | — | 14 May 2021 |
| 30 tablet, film coated in 1 bottle | 71205-633-30 | — | 20 January 2022 |
| 60 tablet, film coated in 1 bottle | 71205-633-60 | — | 20 January 2022 |
| 90 tablet, film coated in 1 bottle | 71205-633-90 | — | 20 January 2022 |
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 Eszopiclone 3 mg tablet.
Other strengths and forms of Eszopiclone
Clinical summary
Eszopiclone is a prescription medicine indicated for the treatment of insomnia. It is available as tablets for oral and oropharyngeal use. MedsAcross supplies Eszopiclone 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 EszopicloneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lunesta prescribing information (Waylis Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Eszopiclone 3 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.