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Medicine

Eszopiclone 1 mg tablet

Eszopiclone · Oral
Available on requestPrescription onlyUS FDAControlled, schedule CIVGeneric name

Eszopiclone 1 mg tablet is a generic prescription medicine for oral use, made by 19 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°F to 30°C…

Key facts

Active ingredient (INN)
Eszopiclone
Brand
Sold under the generic name
Strength
1 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 30 tablets, 500 tablets and 83 more
Manufacturers
Macleods PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaLupinIndiaProficient RxBryant Ranch PrepackBionpharma19 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°F to 30°C (59°F 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 584dc66c-063a-4552-a056-74b811e2bc80, 1582ba77-a4e3-464f-876b-28cc7e41e8f1, 10175591-c1b4-461a-830e-8df982d0d2bf +25NDC 68462-382, 63187-817, 76420-026 +25Application ANDA091166, ANDA202929, ANDA091124 +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 19 labelers. The register lists 86 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle65862-967-01Aurobindo PharmaIndia15 September 2016
30 tablet, film coated in 1 bottle65862-967-30Aurobindo PharmaIndia15 September 2016
100 tablet, film coated in 1 bottle31722-855-01Camber PharmaceuticalsIndia4 January 2024
30 tablet, film coated in 1 bottle31722-855-30Camber PharmaceuticalsIndia4 January 2024
100 tablet, coated in 1 bottle55111-629-01Dr. Reddy's LaboratoriesIndia15 April 2014
500 tablet, coated in 1 bottle55111-629-05Dr. Reddy's LaboratoriesIndia15 April 2014
30 tablet, coated in 1 bottle55111-629-30Dr. Reddy's LaboratoriesIndia15 April 2014
100 tablet, film coated in 1 bottle68462-382-01Glenmark PharmaceuticalsIndia15 April 2014
1000 tablet, film coated in 1 bottle68462-382-10Glenmark PharmaceuticalsIndia15 April 2014
30 tablet, film coated in 1 bottle68462-382-30Glenmark PharmaceuticalsIndia15 April 2014
100 tablet, film coated in 1 bottle68180-322-01LupinIndia15 April 2014
30 tablet, film coated in 1 bottle33342-299-07Macleods PharmaceuticalsIndia31 January 2015
100 tablet, film coated in 1 bottle33342-299-11Macleods PharmaceuticalsIndia31 January 2015
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack33342-299-12Macleods PharmaceuticalsIndia31 January 2015
1000 tablet, film coated in 1 bottle33342-299-44Macleods PharmaceuticalsIndia31 January 2015
100 tablet, film coated in 1 bottle47335-586-08Sun Pharmaceutical IndustriesIndia15 April 2014
1000 tablet, film coated in 1 bottle47335-586-18Sun Pharmaceutical IndustriesIndia15 April 2014
30 tablet, film coated in 1 bottle47335-586-83Sun Pharmaceutical IndustriesIndia15 April 2014
100 tablet, film coated in 1 bottle47335-586-88Sun Pharmaceutical IndustriesIndia15 April 2014
30 tablet, film coated in 1 bottle, plastic69452-347-13Bionpharma1 June 2022
100 tablet, film coated in 1 bottle, plastic69452-347-20Bionpharma1 June 2022
100 tablet, film coated in 1 bottle, plastic0378-5270-01Mylan Pharmaceuticals26 March 2013
30 tablet, film coated in 1 bottle0093-5537-56Teva Pharmaceuticals14 April 2014
30 tablet, film coated in 1 bottle63187-817-30Proficient Rx1 February 2017
60 tablet, film coated in 1 bottle63187-817-60Proficient Rx1 February 2017
90 tablet, film coated in 1 bottle63187-817-90Proficient Rx1 February 2017
30 tablet, film coated in 1 bottle71205-384-30Proficient Rx10 January 2020
60 tablet, film coated in 1 bottle71205-384-60Proficient Rx10 January 2020
90 tablet, film coated in 1 bottle71205-384-90Proficient Rx10 January 2020
30 tablet, film coated in 1 bottle71205-581-30Proficient Rx23 June 2021
60 tablet, film coated in 1 bottle71205-581-60Proficient Rx23 June 2021
90 tablet, film coated in 1 bottle71205-581-90Proficient Rx23 June 2021
30 tablet, film coated in 1 bottle82804-159-30Proficient Rx6 February 2026
60 tablet, film coated in 1 bottle82804-159-60Proficient Rx12 March 2025
90 tablet, film coated in 1 bottle82804-159-90Proficient Rx11 October 2024
30 tablet, film coated in 1 bottle71335-0574-1Bryant Ranch Prepack17 July 2015
60 tablet, film coated in 1 bottle71335-0574-2Bryant Ranch Prepack17 July 2015
90 tablet, film coated in 1 bottle71335-0574-3Bryant Ranch Prepack17 July 2015
10 tablet, film coated in 1 bottle71335-0574-4Bryant Ranch Prepack17 July 2015
120 tablet, film coated in 1 bottle71335-0574-5Bryant Ranch Prepack17 July 2015

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 15 December 2004Drugs@FDA
EU (EMA)Application withdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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

Alternatives

Other makers and brands of Eszopiclone 1 mg tablet.

Compare 1

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 Eszopiclone

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Eszopiclone 1 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.