Medicine
Zonisamide 50 mg capsule
Zonisamide 50 mg capsule is a generic prescription medicine for oral use, made by 10 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F), in a dry…
Key facts
- Active ingredient (INN)
- Zonisamide
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules, 500 capsules and 20 more
- Manufacturers
- Aurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaUnichem LaboratoriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackBluePoint LaboratoriesExelan PharmaceuticalsRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F), in a dry place and protected from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AX15 Zonisamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 January 2006
- Identifiers
- RxCUI 314285, 403966, 403967DailyMed set ID 3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0, fe15e56e-8b86-4a65-825c-31d37dd81612, 994e3ce0-f30b-47b1-aa42-b1ed37fb7c12 +7NDC 29300-429, 68462-129, 70518-4349 +7Application ANDA214492, ANDA077651, ANDA077645 +3
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 capsule in 1 bottle | 59651-379-01 | Aurobindo PharmaIndia | 17 August 2020 |
| 30 capsule in 1 bottle | 59651-379-03 | Aurobindo PharmaIndia | 17 August 2020 |
| 500 capsule in 1 bottle | 59651-379-05 | Aurobindo PharmaIndia | 17 August 2020 |
| 60 capsule in 1 bottle | 59651-379-60 | Aurobindo PharmaIndia | 17 August 2020 |
| 100 capsule in 1 bottle | 68462-129-01 | Glenmark PharmaceuticalsIndia | 30 January 2006 |
| 500 capsule in 1 bottle | 68462-129-05 | Glenmark PharmaceuticalsIndia | 30 January 2006 |
| 30 capsule in 1 bottle | 62756-259-01 | Sun Pharmaceutical IndustriesIndia | 17 March 2006 |
| 100 capsule in 1 bottle | 62756-259-02 | Sun Pharmaceutical IndustriesIndia | 17 March 2006 |
| 100 capsule in 1 bottle | 62756-259-03 | Sun Pharmaceutical IndustriesIndia | 17 March 2006 |
| 1000 capsule in 1 bottle | 62756-259-04 | Sun Pharmaceutical IndustriesIndia | 17 March 2006 |
| 100 capsule in 1 bottle | 29300-429-01 | Unichem LaboratoriesIndia | 9 July 2021 |
| 500 capsule in 1 bottle | 29300-429-05 | Unichem LaboratoriesIndia | 9 July 2021 |
| 100 capsule in 1 bottle | 72578-041-01 | Viona PharmaceuticalsIndia | 4 July 2022 |
| 500 capsule in 1 bottle | 72578-041-05 | Viona PharmaceuticalsIndia | 4 July 2022 |
| 100 capsule in 1 bottle | 70771-1143-1 | Zydus LifesciencesIndia | 22 November 2017 |
| 500 capsule in 1 bottle | 70771-1143-5 | Zydus LifesciencesIndia | 22 November 2017 |
| 100 capsule in 1 bottle | 76282-227-01 | Exelan Pharmaceuticals | 15 March 2021 |
| 100 capsule in 1 bottle | 68001-243-00 | BluePoint Laboratories | 13 March 2014 |
| 30 capsule in 1 bottle | 71335-0962-1 | Bryant Ranch Prepack | 11 September 2020 |
| 60 capsule in 1 bottle | 71335-0962-2 | Bryant Ranch Prepack | 5 October 2018 |
| 90 capsule in 1 bottle | 71335-0962-3 | Bryant Ranch Prepack | 28 January 2022 |
| 120 capsule in 1 bottle | 71335-0962-4 | Bryant Ranch Prepack | 28 January 2022 |
| 100 pouch in 1 box / 1 capsule in 1 pouch | 70518-4349-0 | Remedyrepack | 30 May 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.
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 Zonisamide
Clinical summary
Zonisamide is an anti-epileptic agent indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. It is available as capsules and oral suspension. MedsAcross supplies Zonisamide 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 ZonisamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zonegran prescribing information (Advanz Pharma) · U.S. National Library of Medicine, DailyMed
- Zonegran: European public assessment report (EPAR) · European Medicines Agency
- Zonisamide Viatris (previously Zonisamide Mylan): European public assessment report (EPAR) · European Medicines Agency
Need Zonisamide 50 mg capsule for your hospital or patient?
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