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Medicine

Eslicarbazepine 800 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Eslicarbazepine 800 mg tablet is a generic prescription medicine for oral use, made by 9 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 eslicarbazepine acetate tablets at 20°C to 25°C (68°F to 77°F)…

Key facts

Active ingredient (INN)
Eslicarbazepine
Brand
Sold under the generic name
Strength
800 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 10 blister pack, 90 tablets and 14 more
Manufacturers
Camber PharmaceuticalsIndiaJubilant Cadista PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaLupinIndiaApotexGolden State Medical Supply
Origin register
US FDA, United States
Storage
Store eslicarbazepine acetate tablets at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N03AF04 Eslicarbazepine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 August 2023
Identifiers
RxCUI 1482507, 1482515, 1482521 +1DailyMed set ID 3a3b3e50-6590-0040-e063-6294a90a84c1, 2067fb77-9657-44da-b430-02e8a4efacb5, 22d08671-ac0d-4e3d-8195-929bbb021125 +6NDC 51407-782, 59651-536, 59746-720 +6Application ANDA211236, ANDA216481, ANDA211219 +5

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.

PackCodeLabelerMarketed since
30 tablet in 1 bottle67877-588-30Ascend LaboratoriesIndia6 May 2025
30 tablet in 1 bottle59651-536-30Aurobindo PharmaIndia5 August 2026
30 tablet in 1 bottle31722-431-30Camber PharmaceuticalsIndia3 August 2023
10 blister pack in 1 carton / 10 tablet in 1 blister pack31722-431-32Camber PharmaceuticalsIndia3 August 2023
90 tablet in 1 bottle31722-431-90Camber PharmaceuticalsIndia3 August 2023
30 tablet in 1 bottle43598-687-30Dr. Reddy's LaboratoriesIndia6 May 2025
90 tablet in 1 bottle43598-687-90Dr. Reddy's LaboratoriesIndia6 May 2025
500 tablet in 1 bottle59746-720-05Jubilant Cadista PharmaceuticalsIndia1 May 2026
30 tablet in 1 bottle59746-720-30Jubilant Cadista PharmaceuticalsIndia1 May 2026
90 tablet in 1 bottle59746-720-90Jubilant Cadista PharmaceuticalsIndia1 May 2026
30 tablet in 1 bottle68180-293-06LupinIndia6 May 2025
500 tablet in 1 bottle13668-541-05Torrent PharmaceuticalsIndia6 May 2025
30 tablet in 1 bottle13668-541-30Torrent PharmaceuticalsIndia6 May 2025
60 tablet in 1 bottle13668-541-60Torrent PharmaceuticalsIndia6 May 2025
30 tablet in 1 bottle60505-4661-3Apotex6 May 2025
90 tablet in 1 bottle60505-4661-9Apotex6 May 2025
30 tablet in 1 bottle51407-782-30Golden State Medical Supply12 May 2025

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 8 November 2013Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean 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 Eslicarbazepine 800 mg tablet.

Compare 1

Other strengths and forms of Eslicarbazepine

Clinical summary

Eslicarbazepine is a prescription medicine indicated for the treatment of partial-onset seizures in patients 4 years of age and older. It is available as tablets and kits for oral use. MedsAcross supplies Eslicarbazepine 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 Eslicarbazepine

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

Data sources

Need Eslicarbazepine 800 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.