Medicine
Oxcarbazepine 300 mg/5 mL powder for oral suspension
Oxcarbazepine 300 mg/5 mL powder for oral suspension is a generic prescription medicine for oral use, 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Oxcarbazepine
- Brand
- Sold under the generic name
- Strength
- 300 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Manufacturer
- Macleods PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store oxcarbazepine oral suspension, USP in the original container.
- 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
- 11 July 2025
- Identifiers
- RxCUI 283536DailyMed set ID 962098cc-2d84-4723-a296-b110f1fd659eNDC 33342-259Application ANDA207300
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 250 mL in 1 bottle | 33342-259-67 | Macleods PharmaceuticalsIndia | 11 July 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 300 mg/5 mL powder for oral suspension 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.