Medicine
Topiramate 100 mg tablet
Topiramate 100 mg tablet is a generic prescription medicine for oral use, made by 29 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),. Protect from moisture.
Key facts
- Active ingredient (INN)
- Topiramate
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets, 500 tablets, 1000 tablets and 157 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaZydus LifesciencesIndiaCiplaIndiaUnichem LaboratoriesIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaCamber PharmaceuticalsIndiaC29 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F),. Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AX11 Topiramate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 March 2009
- Identifiers
- RxCUI 151226, 199888, 199889 +1DailyMed set ID 3b18b43c-0de2-4acf-b0d5-f1b601d496de, 53c3f980-f05b-c671-e063-6294a90a77d5, 164cb1f7-1a41-675f-e063-6294a90ae0dd +37NDC 71610-492, 50268-808, 61919-213 +37Application ANDA079162, ANDA078235, ANDA076343 +5
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 29 labelers. The register lists 160 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet in 1 bottle | 69097-124-03 | CiplaIndia | 12 June 2014 |
| 500 tablet in 1 bottle | 69097-124-12 | CiplaIndia | 12 June 2014 |
| 1000 tablet in 1 bottle | 69097-124-15 | CiplaIndia | 12 June 2014 |
| 60 tablet in 1 bottle | 69097-818-03 | CiplaIndia | 22 July 2016 |
| 500 tablet in 1 bottle | 69097-818-12 | CiplaIndia | 22 July 2016 |
| 1000 tablet in 1 bottle | 69097-818-15 | CiplaIndia | 22 July 2016 |
| 100 tablet, film coated in 1 bottle | 47335-711-08 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 1000 tablet, film coated in 1 bottle | 47335-711-18 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 30 tablet, film coated in 1 bottle | 47335-711-83 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 60 tablet, film coated in 1 bottle | 47335-711-86 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 100 tablet, film coated in 1 bottle | 47335-711-88 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 100 tablet, film coated in 1 bottle | 62756-711-08 | Sun Pharmaceutical IndustriesIndia | 27 March 2009 |
| 500 tablet, film coated in 1 bottle | 62756-711-13 | Sun Pharmaceutical IndustriesIndia | 27 March 2009 |
| 1000 tablet, film coated in 1 bottle | 62756-711-18 | Sun Pharmaceutical IndustriesIndia | 27 March 2009 |
| 30 tablet, film coated in 1 bottle | 62756-711-83 | Sun Pharmaceutical IndustriesIndia | 27 March 2009 |
| 60 tablet, film coated in 1 bottle | 62756-711-86 | Sun Pharmaceutical IndustriesIndia | 27 March 2009 |
| 100 tablet, film coated in 1 bottle | 62756-711-88 | Sun Pharmaceutical IndustriesIndia | 27 March 2009 |
| 100 tablet, film coated in 1 bottle | 65841-649-01 | Zydus LifesciencesIndia | 27 March 2009 |
| 500 tablet, film coated in 1 bottle | 65841-649-05 | Zydus LifesciencesIndia | 27 March 2009 |
| 60 tablet, film coated in 1 bottle | 65841-649-14 | Zydus LifesciencesIndia | 27 March 2009 |
| 90 tablet, film coated in 1 bottle | 65841-649-16 | Zydus LifesciencesIndia | 27 March 2009 |
| 100 tablet, film coated in 1 bottle | 68382-140-01 | Zydus LifesciencesIndia | 27 March 2009 |
| 500 tablet, film coated in 1 bottle | 68382-140-05 | Zydus LifesciencesIndia | 27 March 2009 |
| 60 tablet, film coated in 1 bottle | 68382-140-14 | Zydus LifesciencesIndia | 27 March 2009 |
| 90 tablet, film coated in 1 bottle | 68382-140-16 | Zydus LifesciencesIndia | 27 March 2009 |
| 500 tablet, film coated in 1 bottle | 65862-173-05 | Aurobindo PharmaIndia | 11 April 2022 |
| 60 tablet, film coated in 1 bottle | 65862-173-60 | Aurobindo PharmaIndia | 27 March 2009 |
| 1000 tablet, film coated in 1 bottle | 65862-173-99 | Aurobindo PharmaIndia | 11 April 2022 |
| 500 tablet in 1 bottle | 31722-183-05 | Camber PharmaceuticalsIndia | 22 September 2021 |
| 60 tablet in 1 bottle | 31722-183-60 | Camber PharmaceuticalsIndia | 22 September 2021 |
| 500 tablet, film coated in 1 bottle | 68462-109-05 | Glenmark PharmaceuticalsIndia | 30 July 2020 |
| 1000 tablet, film coated in 1 bottle | 68462-109-10 | Glenmark PharmaceuticalsIndia | 27 March 2009 |
| 60 tablet, film coated in 1 bottle | 68462-109-60 | Glenmark PharmaceuticalsIndia | 27 March 2009 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-117-01 | Unichem LaboratoriesIndia | 1 July 2013 |
| 500 tablet, film coated in 1 bottle, plastic | 29300-117-05 | Unichem LaboratoriesIndia | 1 July 2013 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-117-10 | Unichem LaboratoriesIndia | 1 July 2013 |
| 60 tablet, film coated in 1 bottle, plastic | 29300-117-16 | Unichem LaboratoriesIndia | 1 July 2013 |
| 30 tablet in 1 bottle | 61919-213-30 | C | 17 April 2024 |
| 60 tablet in 1 bottle | 61919-213-60 | C | 17 April 2024 |
| 120 tablet in 1 bottle | 61919-213-72 | C | 17 April 2024 |
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 24 December 1996 | 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 Topiramate 100 mg tablet.
Other strengths and forms of Topiramate
Clinical summary
Topiramate is a prescription medicine indicated for epilepsy, among other approved uses. It is available as tablets, extended-release capsules and capsules for oral use. MedsAcross supplies Topiramate 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 TopiramateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Topamax prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Topiramate 100 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.