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Medicine

Zonisamide 100 mg capsule

Zonisamide · Oral
Available on requestPrescription onlyUS FDAGeneric name

Zonisamide 100 mg capsule is a generic prescription medicine for oral use, made by 18 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

Available on request

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). Keep in dry place and protect…

Key facts

Active ingredient (INN)
Zonisamide
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Capsule
Route
Oral
Packs
100 capsules, 30 capsules, 500 capsules and 62 more
Manufacturers
Aurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaCiplaIndiaGlenmark PharmaceuticalsIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackExelan Pharmaceuticals18 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20 • C to 25 • C (68 • F to 77 • F). Keep in dry place and protect 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 19b059f0-a08a-f75a-e063-6294a90a57db, b20a51ef-255e-1eb0-c0e1-461cde46b887, e8f368cb-6a07-4178-95fa-1d5a209171ed +22NDC 80425-0392, 50268-816, 69097-861 +22Application ANDA077625, ANDA077869, ANDA077634 +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

A sample of 40 packs from 18 labelers. The register lists 65 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 capsule in 1 bottle59651-380-01Aurobindo PharmaIndia17 August 2020
30 capsule in 1 bottle59651-380-03Aurobindo PharmaIndia17 August 2020
500 capsule in 1 bottle59651-380-05Aurobindo PharmaIndia17 August 2020
60 capsule in 1 bottle59651-380-60Aurobindo PharmaIndia17 August 2020
100 capsule in 1 bottle69097-861-07CiplaIndia13 July 2016
500 capsule in 1 bottle69097-861-12CiplaIndia13 July 2016
100 capsule in 1 bottle68462-130-01Glenmark PharmaceuticalsIndia30 January 2006
500 capsule in 1 bottle68462-130-05Glenmark PharmaceuticalsIndia30 January 2006
30 capsule in 1 bottle62756-260-01Sun Pharmaceutical IndustriesIndia17 March 2006
100 capsule in 1 bottle62756-260-03Sun Pharmaceutical IndustriesIndia17 March 2006
1000 capsule in 1 bottle62756-260-04Sun Pharmaceutical IndustriesIndia17 March 2006
500 capsule in 1 bottle62756-260-05Sun Pharmaceutical IndustriesIndia17 March 2006
100 capsule in 1 bottle29300-430-01Unichem LaboratoriesIndia9 July 2021
500 capsule in 1 bottle29300-430-05Unichem LaboratoriesIndia9 July 2021
100 capsule in 1 bottle72578-042-01Viona PharmaceuticalsIndia4 July 2022
500 capsule in 1 bottle72578-042-05Viona PharmaceuticalsIndia4 July 2022
1000 capsule in 1 bottle72578-042-10Viona PharmaceuticalsIndia4 July 2022
1000 capsule in 1 bottle70771-1144-0Zydus LifesciencesIndia22 November 2017
100 capsule in 1 bottle70771-1144-1Zydus LifesciencesIndia22 November 2017
500 capsule in 1 bottle70771-1144-5Zydus LifesciencesIndia22 November 2017
100 capsule in 1 bottle76282-228-01Exelan Pharmaceuticals5 July 2006
100 capsule in 1 bottle63629-3293-1Bryant Ranch Prepack13 April 2010
90 capsule in 1 bottle63629-3293-2Bryant Ranch Prepack18 November 2008
30 capsule in 1 bottle63629-3293-3Bryant Ranch Prepack29 March 2013
60 capsule in 1 bottle63629-3293-4Bryant Ranch Prepack10 November 2011
120 capsule in 1 bottle63629-3293-5Bryant Ranch Prepack31 May 2013
100 capsule in 1 bottle71335-0486-1Bryant Ranch Prepack27 October 2026
90 capsule in 1 bottle71335-0486-2Bryant Ranch Prepack19 April 2024
30 capsule in 1 bottle71335-0486-3Bryant Ranch Prepack2 May 2023
60 capsule in 1 bottle71335-0486-4Bryant Ranch Prepack27 October 2026
120 capsule in 1 bottle71335-0486-5Bryant Ranch Prepack27 October 2026
100 capsule in 1 bottle71335-2797-1Bryant Ranch Prepack13 October 2025
90 capsule in 1 bottle71335-2797-2Bryant Ranch Prepack13 October 2025
30 capsule in 1 bottle71335-2797-3Bryant Ranch Prepack13 October 2025
60 capsule in 1 bottle71335-2797-4Bryant Ranch Prepack13 October 2025
120 capsule in 1 bottle71335-2797-5Bryant Ranch Prepack13 October 2025
100 capsule in 1 bottle71335-9679-1Bryant Ranch Prepack6 April 2023
90 capsule in 1 bottle71335-9679-2Bryant Ranch Prepack6 April 2023
30 capsule in 1 bottle71335-9679-3Bryant Ranch Prepack6 April 2023
60 capsule in 1 bottle71335-9679-4Bryant Ranch Prepack6 April 2023

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 27 March 2000Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 Zonisamide 100 mg capsule.

Compare 1

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 Zonisamide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Zonisamide 100 mg capsule 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.