Medicine
Oxcarbazepine 300 mg/5 mL oral suspension
Oxcarbazepine 300 mg/5 mL oral suspension is a generic prescription medicine for oral use, made by 15 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° 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
- Oral suspension
- Route
- Oral
- Packs
- 250 mL, 1 bottle, 10 cup and 16 more
- Manufacturers
- Ascend LaboratoriesIndiaBioconIndiaCamber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAmneal PharmaceuticalsBionpharmaBryant Ranch PrepackChartwell RXAdvagen PharmaChartwell Governmental & Specialty RX
- 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
- 4 June 2012
- Identifiers
- RxCUI 283536DailyMed set ID 4ef6a941-a017-40f2-a50a-ab66c43b3347, d3684d55-0564-4849-bdf6-b91f22a3e28c, 1746d95f-c529-45ba-a520-0c135e8edda8 +13NDC 72888-074, 10135-798, 72603-252 +13Application ANDA215726, ANDA217782, ANDA216749 +7
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 |
|---|---|---|---|
| 250 mL in 1 bottle | 67877-532-58 | Ascend LaboratoriesIndia | 1 January 2020 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 70377-117-11 | BioconIndia | 31 May 2024 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 31722-687-25 | Camber PharmaceuticalsIndia | 20 October 2023 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 72205-354-85 | Novadoz PharmaceuticalsIndia | 29 May 2026 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 72888-074-14 | Advagen Pharma | 14 February 2024 |
| 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 65162-649-48 | Amneal Pharmaceuticals | 4 June 2012 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 65162-649-78 | Amneal Pharmaceuticals | 4 June 2012 |
| 1 bottle, glass in 1 carton / 250 mL in 1 bottle, glass | 69452-125-50 | Bionpharma | 14 February 2023 |
| 1 bottle, plastic in 1 carton / 250 mL in 1 bottle, plastic | 69452-125-51 | Bionpharma | 1 December 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-841-24 | Chartwell Governmental & Specialty RX | 19 December 2025 |
| 20 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 62135-841-24 | Chartwell RX | 27 March 2024 |
| 250 mL in 1 bottle | 62135-841-54 | Chartwell RX | 27 March 2024 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 42806-600-22 | Epic Pharma | 30 January 2023 |
| 250 mL in 1 bottle, glass | 85742-007-06 | Kanchan Healthcare | 1 May 2025 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 72162-2088-2 | Bryant Ranch Prepack | 4 June 2012 |
| 250 mL in 1 bottle, glass | 72162-2631-2 | Bryant Ranch Prepack | 23 April 2026 |
| 250 mL in 1 bottle, glass | 10135-798-41 | Marlex Pharmaceuticals | 1 May 2025 |
| 1 bottle in 1 carton / 250 mL in 1 bottle | 72603-252-01 | NorthStar RxLLC | 1 May 2024 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 68094-123-62 | Precision Dose | 13 September 2017 |
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 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.