Medicine
Topiramate 100 mg extended-release capsule
Topiramate 100 mg extended-release capsule is a generic prescription medicine for oral use, made by 14 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). Store in well-closed container. Protect…
Key facts
- Active ingredient (INN)
- Topiramate
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 36 more
- Manufacturers
- Zydus LifesciencesIndiaAscend LaboratoriesIndiaAjanta PharmaIndiaGlenmark PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaLupinIndiaUpsher-Smith LaboratoriesPar HealthTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store in well-closed container. Protect from moisture and light.
- 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
- 7 July 2014
- Identifiers
- RxCUI 1436239, 1437278, 1437283 +6DailyMed set ID 4f20155f-05b9-40ec-af34-3b58aa8d60d4, 54bfabce-1f8a-40ee-8b55-efce8fe6fbf1, b5f8da43-6daf-413c-9dcd-363617973738 +15NDC 0480-2358, 68462-374, 72603-122 +15Application ANDA206210, ANDA210278, ANDA219564 +11
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, extended release in 1 bottle | 68382-769-01 | Zydus LifesciencesIndia | 10 September 2024 |
| 500 capsule, extended release in 1 bottle | 68382-769-05 | Zydus LifesciencesIndia | 10 September 2024 |
| 30 capsule, extended release in 1 bottle | 68382-769-06 | Zydus LifesciencesIndia | 10 September 2024 |
| 90 capsule, extended release in 1 bottle | 68382-769-16 | Zydus LifesciencesIndia | 10 September 2024 |
| 3 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack | 68382-769-78 | Zydus LifesciencesIndia | 10 September 2024 |
| 30 capsule, extended release in 1 bottle | 70710-1041-3 | Zydus LifesciencesIndia | 17 January 2023 |
| 90 capsule, extended release in 1 bottle | 70710-1041-9 | Zydus LifesciencesIndia | 17 January 2023 |
| 100 capsule, extended release in 1 bottle | 70771-1317-1 | Zydus LifesciencesIndia | 5 April 2018 |
| 30 capsule, extended release in 1 bottle | 70771-1317-3 | Zydus LifesciencesIndia | 5 April 2018 |
| 10 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack | 70771-1317-4 | Zydus LifesciencesIndia | 5 April 2018 |
| 500 capsule, extended release in 1 bottle | 70771-1317-5 | Zydus LifesciencesIndia | 5 April 2018 |
| 90 capsule, extended release in 1 bottle | 70771-1317-9 | Zydus LifesciencesIndia | 5 April 2018 |
| 30 capsule, extended release in 1 bottle | 70771-1658-3 | Zydus LifesciencesIndia | 17 January 2023 |
| 90 capsule, extended release in 1 bottle | 70771-1658-9 | Zydus LifesciencesIndia | 17 January 2023 |
| 100 capsule, extended release in 1 bottle | 27241-229-01 | Ajanta PharmaIndia | 15 August 2023 |
| 30 capsule, extended release in 1 bottle | 27241-229-30 | Ajanta PharmaIndia | 15 August 2023 |
| 30 capsule, extended release in 1 bottle | 27241-298-30 | Ajanta PharmaIndia | 2 September 2025 |
| 100 capsule, extended release in 1 bottle | 67877-795-01 | Ascend LaboratoriesIndia | 15 October 2026 |
| 500 capsule, extended release in 1 bottle | 67877-795-05 | Ascend LaboratoriesIndia | 15 October 2026 |
| 30 capsule, extended release in 1 bottle | 67877-795-30 | Ascend LaboratoriesIndia | 15 October 2026 |
| 1 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack | 67877-795-33 | Ascend LaboratoriesIndia | 15 October 2026 |
| 30 capsule, extended release in 1 bottle | 31722-549-30 | Camber PharmaceuticalsIndia | 1 April 2026 |
| 100 capsule, extended release in 1 bottle | 43598-941-01 | Dr. Reddy's LaboratoriesIndia | 1 February 2026 |
| 30 capsule, extended release in 1 bottle | 43598-941-30 | Dr. Reddy's LaboratoriesIndia | 1 February 2026 |
| 500 capsule, extended release in 1 bottle | 68462-374-05 | Glenmark PharmaceuticalsIndia | 1 February 2021 |
| 30 capsule, extended release in 1 bottle | 68462-374-30 | Glenmark PharmaceuticalsIndia | 1 February 2021 |
| 90 capsule, extended release in 1 bottle | 68462-374-90 | Glenmark PharmaceuticalsIndia | 1 February 2021 |
| 30 capsule, extended release in 1 bottle | 70748-277-06 | LupinIndia | 3 February 2026 |
| 30 capsule, extended release in 1 bottle | 27808-327-01 | Cranbury Pharmaceuticals | 1 October 2026 |
| 100 capsule, extended release in 1 bottle | 10370-367-01 | Par Health | 24 May 2023 |
| 30 capsule, extended release in 1 bottle | 10370-367-11 | Par Health | 24 May 2023 |
| 100 capsule, extended release in 1 bottle | 0480-2358-01 | Teva Pharmaceuticals | 3 May 2023 |
| 30 capsule, extended release in 1 bottle | 0480-2358-56 | Teva Pharmaceuticals | 3 May 2023 |
| 500 capsule, extended release in 1 bottle | 0832-1074-15 | Upsher-Smith Laboratories | 7 July 2014 |
| 1 bottle in 1 carton / 30 capsule, extended release in 1 bottle | 0832-1074-30 | Upsher-Smith Laboratories | 7 July 2014 |
| 1 bottle in 1 carton / 90 capsule, extended release in 1 bottle | 0832-1074-90 | Upsher-Smith Laboratories | 7 July 2014 |
| 30 capsule, extended release in 1 bottle | 69680-179-30 | Vitruvias Therapeutics | 7 April 2025 |
| 30 capsule, extended release in 1 bottle | 42291-957-30 | AvKARE | 30 October 2024 |
| 30 capsule, extended release in 1 bottle | 72603-122-01 | NorthStar RxLLC | 1 January 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.
| 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 extended-release capsule.
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 extended-release 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.