Medicine
Aptiom 800 mg tablet
Aptiom 800 mg tablet is a prescription medicine containing Eslicarbazepine for oral use, marketed by Sumitomo Pharma, 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 APTIOM tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Eslicarbazepine
- Brand
- Aptiom
- Strength
- 800 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 4 blister pack, 30 tablets
- Marketing authorisation holder
- Sumitomo Pharma
- Manufacturer
- Sumitomo Pharma
- Origin register
- US FDA, United States
- Storage
- Store APTIOM tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 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
- 7 April 2014
- Identifiers
- RxCUI 1482507, 1482513, 1482515 +7DailyMed set ID 3d0c9554-eaeb-4694-8089-00133fcadce3NDC 63402-208Application NDA022416
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 4 blister pack in 1 carton / 7 tablet in 1 blister pack | 63402-208-28 | Sumitomo Pharma | 7 April 2014 |
| 30 tablet in 1 bottle | 63402-208-30 | Sumitomo Pharma | 7 April 2014 |
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 Eslicarbazepine 800 mg tablet.
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 EslicarbazepineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Aptiom prescribing information (Sumitomo Pharma) · U.S. National Library of Medicine, DailyMed
- Zebinix: European public assessment report (EPAR) · European Medicines Agency
Need Aptiom 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.