United States· US:0480-2358_38168585-df97-4809-8f00-a61122c7259f
Topiramate
A medicinal product containing topiramate, registered in United States by Teva Pharmaceuticals, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- Topiramate
- Manufacturer
- Teva Pharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 2
- ndc110480235801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-01)
- ndc11048023585630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-56)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Topiramate in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaTOLEPSOARDEZ Pharma, spol. s r.o., Kosoř
- United KingdomTopamax 100mg tabletsCST Pharma Ltd
- FinlandMaratoopiratiopharm GmbH
- SpainACOMICIL 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAdamed Laboratorios S.L.U.
- CanadaACH-TOPIRAMATEACCORD HEALTHCARE INC
- SwedenTopamac 200 mg Filmdragerad tablettMedartuum AB
- NetherlandsTopamax 100 mg, filmomhulde tablettenEuro Registratie Collectief B.V.
- ItalyTOPAMAXJANSSEN CILAG S.P.A.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Topamax, Topilex
- Belgium · Topamax, Topiramate Eg
- Bulgaria · Topilex, Талопам
- Cyprus · Topamax, Topiramate Aurobindo
- Czechia · Tolepso, Topamax
- Germany · Migräne, Topamax
- Denmark · Maritop, Topimax
- Estonia · Topamax,, Topiramate Elvim
- Spain · Acomicil, Topamax
- Finland · Topimax, Topiramat Orion
- France · Epitomax, Topiramate Arrow
- United Kingdom (Northern Ireland) · Topamax, Topiramate
- Greece · Jadix, Topamac
- Croatia · Topamax
- Hungary · Etopro, Topamax
- Ireland · Topamax, Topamax Sprinkle
- Iceland · Topimax, Topiramat Actavis
- Italy · Topamax, Topiramato Aurobindo
- Lithuania · Topamax, Topiramat Orion
- Luxembourg · Topamax
- Latvia · Topamax, Topiramat Orion
- Malta · Topamax, Topiramate Accord Healthcare
- Netherlands · Topamax, Topamax Sprinkle
- Norway · Topimax, Topiramat Sandoz
- Poland · Etopro, Oritop
- Portugal · Topamax, Topiramato Alter
- Romania · Topilex, Topiramat Teva
- Sweden · Topimax, Topiramat 1a Farma
- Slovenia · Topamax
- Slovakia · Talopam, Topimark
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/fb2377a5-cd1b-4351-a91e-cf18c0e84723 GET /v1/drugs/fb2377a5-cd1b-4351-a91e-cf18c0e84723?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 3
},
"productid": "0480-2358_38168585-df97-4809-8f00-a61122c7259f",
"productndc": "0480-2358",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOPIRAMATE",
"proprietary_name": "Topiramate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206210",
"marketing_category": "ANDA",
"nonproprietary_name": "Topiramate",
"start_marketing_date": "20230503",
"active_numerator_strength": "100"
}See everything about topiramate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.