Medicine
Oxcarbazepine 600 mg extended-release tablet
Oxcarbazepine 600 mg extended-release tablet is a generic prescription medicine for oral use, made by 4 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Oxcarbazepine
- Brand
- Sold under the generic name
- Strength
- 600 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets and 2 more
- Manufacturers
- Ajanta PharmaIndiaAurobindo PharmaIndiaApotexIngenus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AF02 Oxcarbazepine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 February 2024
- Identifiers
- RxCUI 1365653, 1365842, 1365844DailyMed set ID d947e9b1-2a15-4048-bb4e-fe56b6851848, 70798ca9-0eda-49c0-8a7c-b775b6ae3d69, a20e4a95-8ee1-e702-003e-e353ec1ee133 +1NDC 27241-239, 50742-613, 60505-4130 +1Application ANDA217659, ANDA215796, ANDA213369 +1
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, extended release in 1 bottle | 27241-239-01 | Ajanta PharmaIndia | 22 February 2024 |
| 100 tablet, film coated, extended release in 1 bottle | 59651-787-01 | Aurobindo PharmaIndia | 16 October 2026 |
| 500 tablet, extended release in 1 bottle | 60505-4130-5 | Apotex | 3 September 2024 |
| 100 tablet, extended release in 1 bottle | 60505-4130-7 | Apotex | 3 September 2024 |
| 100 tablet, extended release in 1 bottle, plastic | 50742-613-01 | Ingenus Pharmaceuticals | 1 June 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 January 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Other strengths and forms of Oxcarbazepine
Clinical summary
Oxcarbazepine is an anti-epileptic agent. It is available as tablets, oral suspension and extended-release tablets. MedsAcross supplies Oxcarbazepine 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 OxcarbazepineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Trileptal prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Oxcarbazepine 600 mg extended-release 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.