Medicine
Topiramate 15 mg capsule
Topiramate 15 mg capsule is a generic prescription medicine for oral use, made by 6 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
Topiramate capsules should be stored in tightly-closed containers at or below…
Key facts
- Active ingredient (INN)
- Topiramate
- Brand
- Sold under the generic name
- Strength
- 15 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 1000 capsules and 18 more
- Manufacturers
- Zydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaAdvagen PharmaUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Topiramate capsules should be stored in tightly-closed containers at or below 25°C (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
- 14 October 2009
- Identifiers
- RxCUI 205315, 205316, 252413DailyMed set ID 872927eb-0b61-44bb-9892-3c700b6f2181, e4886adf-199d-4b19-a4ef-75f8f94cb54e, 48169bbc-4fb2-4bc4-9bdd-de71bf7722df +4NDC 68462-218, 68382-004, 72888-228 +4Application ANDA217869, ANDA078877, ANDA216683 +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, coated pellets in 1 bottle | 65841-651-01 | Zydus LifesciencesIndia | 14 October 2009 |
| 500 capsule, coated pellets in 1 bottle | 65841-651-05 | Zydus LifesciencesIndia | 14 October 2009 |
| 1000 capsule, coated pellets in 1 bottle | 65841-651-10 | Zydus LifesciencesIndia | 14 October 2009 |
| 60 capsule, coated pellets in 1 bottle | 65841-651-14 | Zydus LifesciencesIndia | 14 October 2009 |
| 90 capsule, coated pellets in 1 bottle | 65841-651-16 | Zydus LifesciencesIndia | 14 October 2009 |
| 100 capsule, coated pellets in 1 bottle | 68382-004-01 | Zydus LifesciencesIndia | 14 October 2009 |
| 500 capsule, coated pellets in 1 bottle | 68382-004-05 | Zydus LifesciencesIndia | 14 October 2009 |
| 1000 capsule, coated pellets in 1 bottle | 68382-004-10 | Zydus LifesciencesIndia | 14 October 2009 |
| 60 capsule, coated pellets in 1 bottle | 68382-004-14 | Zydus LifesciencesIndia | 14 October 2009 |
| 90 capsule, coated pellets in 1 bottle | 68382-004-16 | Zydus LifesciencesIndia | 14 October 2009 |
| 500 capsule in 1 bottle | 67877-868-05 | Ascend LaboratoriesIndia | 5 August 2024 |
| 1 blister pack in 1 carton / 10 capsule in 1 blister pack | 67877-868-33 | Ascend LaboratoriesIndia | 5 August 2024 |
| 60 capsule in 1 bottle | 67877-868-60 | Ascend LaboratoriesIndia | 5 August 2024 |
| 60 capsule in 1 bottle | 59651-452-60 | Aurobindo PharmaIndia | 27 September 2023 |
| 60 capsule, coated pellets in 1 bottle | 68462-218-60 | Glenmark PharmaceuticalsIndia | 16 July 2024 |
| 500 capsule in 1 bottle | 72888-228-05 | Advagen Pharma | 27 May 2025 |
| 120 capsule in 1 bottle | 72888-228-12 | Advagen Pharma | 27 May 2025 |
| 30 capsule in 1 bottle | 72888-228-30 | Advagen Pharma | 27 May 2025 |
| 60 capsule in 1 bottle | 72888-228-60 | Advagen Pharma | 27 May 2025 |
| 240 capsule in 1 bottle | 72888-228-67 | Advagen Pharma | 27 May 2025 |
| 60 capsule in 1 bottle, plastic | 24979-210-04 | Upsher-Smith Laboratories | 5 December 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 15 mg 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 15 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.