Medicine
Oxcarbazepine 300 mg tablet
Oxcarbazepine 300 mg tablet is a generic prescription medicine for oral use, made by 22 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
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 70 more
- Manufacturers
- Zydus LifesciencesIndiaSun Pharmaceutical IndustriesIndiaCamber PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaUmedica LaboratoriesIndiaAdvagen PharmaRemedyrepackBreckenridge PharmaceuticalANI PharmaceuticalsXLCare Pharmaceuticals22 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°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
- N03AF02 Oxcarbazepine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 October 2007
- Identifiers
- RxCUI 312137, 312136, 312138DailyMed set ID 433d9d03-a36e-42c6-8e4d-f333ed60e45a, 512ab25c-ea79-1e59-e063-6294a90ae9a0, 1c713b59-a628-42e6-b166-ae71c3913284 +33NDC 82804-209, 67046-2084, 68462-138 +33Application ANDA215939, ANDA077802, ANDA078069 +6
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 22 labelers. The register lists 73 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 68382-692-01 | Zydus LifesciencesIndia | 10 July 2025 |
| 500 tablet in 1 bottle | 68382-692-05 | Zydus LifesciencesIndia | 10 July 2025 |
| 1000 tablet in 1 bottle | 68382-692-10 | Zydus LifesciencesIndia | 10 July 2025 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-692-30 | Zydus LifesciencesIndia | 10 July 2025 |
| 1000 tablet in 1 bottle | 70771-1843-0 | Zydus LifesciencesIndia | 10 July 2025 |
| 100 tablet in 1 bottle | 70771-1843-1 | Zydus LifesciencesIndia | 10 July 2025 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1843-4 | Zydus LifesciencesIndia | 10 July 2025 |
| 500 tablet in 1 bottle | 70771-1843-5 | Zydus LifesciencesIndia | 10 July 2025 |
| 100 tablet, film coated in 1 bottle | 31722-024-01 | Camber PharmaceuticalsIndia | 11 January 2022 |
| 500 tablet, film coated in 1 bottle | 31722-024-05 | Camber PharmaceuticalsIndia | 10 March 2023 |
| 1000 tablet, film coated in 1 bottle | 31722-024-10 | Camber PharmaceuticalsIndia | 10 March 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-024-31 | Camber PharmaceuticalsIndia | 11 January 2022 |
| 100 tablet, film coated in 1 bottle | 68462-138-01 | Glenmark PharmaceuticalsIndia | 9 October 2007 |
| 500 tablet, film coated in 1 bottle | 68462-138-05 | Glenmark PharmaceuticalsIndia | 9 October 2007 |
| 100 tablet, film coated in 1 bottle | 62756-184-08 | Sun Pharmaceutical IndustriesIndia | 9 October 2007 |
| 500 tablet, film coated in 1 bottle | 62756-184-13 | Sun Pharmaceutical IndustriesIndia | 9 October 2007 |
| 1000 tablet, film coated in 1 bottle | 62756-184-18 | Sun Pharmaceutical IndustriesIndia | 9 October 2007 |
| 30 tablet, film coated in 1 bottle | 62756-184-83 | Sun Pharmaceutical IndustriesIndia | 9 October 2007 |
| 100 tablet, film coated in 1 bottle | 62756-184-88 | Sun Pharmaceutical IndustriesIndia | 9 October 2007 |
| 100 tablet, film coated in 1 bottle | 60290-068-01 | Umedica LaboratoriesIndia | 1 January 2026 |
| 500 tablet, film coated in 1 bottle | 60290-068-02 | Umedica LaboratoriesIndia | 1 January 2026 |
| 100 tablet, film coated in 1 bottle | 72888-088-01 | Advagen Pharma | 19 March 2021 |
| 500 tablet, film coated in 1 bottle | 72888-088-05 | Advagen Pharma | 19 March 2021 |
| 30 tablet, film coated in 1 bottle | 72888-088-30 | Advagen Pharma | 19 March 2021 |
| 100 tablet in 1 bottle | 72888-460-01 | Advagen Pharma | 20 May 2025 |
| 500 tablet in 1 bottle | 72888-460-02 | Advagen Pharma | 20 May 2025 |
| 100 tablet, film coated in 1 bottle | 51991-054-01 | Breckenridge Pharmaceutical | 29 January 2025 |
| 500 tablet, film coated in 1 bottle | 51991-054-05 | Breckenridge Pharmaceutical | 29 January 2025 |
| 100 tablet, film coated in 1 bottle | 51991-293-01 | Breckenridge Pharmaceutical | 11 January 2008 |
| 500 tablet, film coated in 1 bottle | 51991-293-05 | Breckenridge Pharmaceutical | 11 January 2008 |
| 100 tablet, film coated in 1 bottle | 62559-221-01 | ANI Pharmaceuticals | 15 July 2025 |
| 500 tablet, film coated in 1 bottle | 62559-221-05 | ANI Pharmaceuticals | 15 July 2025 |
| 100 tablet, film coated in 1 bottle | 72865-284-01 | XLCare Pharmaceuticals | 18 July 2024 |
| 500 tablet, film coated in 1 bottle | 72865-284-05 | XLCare Pharmaceuticals | 18 July 2024 |
| 100 tablet, film coated in 1 bottle | 90096-172-01 | Zameer Pharmaceuticals | 6 July 2026 |
| 30 tablet, film coated in 1 blister pack | 70518-2276-0 | Remedyrepack | 22 August 2019 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-2370-2 | Remedyrepack | 4 October 2024 |
| 30 tablet, film coated in 1 blister pack | 70518-3237-2 | Remedyrepack | 11 February 2025 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-3921-0 | Remedyrepack | 22 November 2023 |
| 30 tablet, film coated in 1 blister pack | 70518-4663-0 | Remedyrepack | 18 May 2026 |
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
Alternatives
Other makers and brands of Oxcarbazepine 300 mg tablet.
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 300 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.