United States· US:68462-308_74611591-657b-40e8-8ae1-1e5533a05d97
DIMETHYL FUMARATE
A medicinal product containing dimethyl fumarate, registered in United States by Glenmark Pharmaceuticals Inc., USA.
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
- DIMETHYL FUMARATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1168462-308-05
- ndc1168462-308-60
- ndc1168462-308-68
- ndc116846230805500 CAPSULE in 1 BOTTLE (68462-308-05)
- ndc11684623086060 CAPSULE in 1 BOTTLE (68462-308-60)
- ndc11684623086846 CAPSULE in 1 BOTTLE (68462-308-68)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dimethyl fumarate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaADIFEMUVipharm S.A., Ożarów Mazowiecki
- SwitzerlandDimethylfumarat Accord
- PolandAdifemuVipharm S.A.
- IcelandArbicenEGIS Pharmaceuticals PLC
- FinlandBalfumonG.L. Pharma GmbH
- SwedenDimethyl fumarate 1A Farma 120 mg Enterokapsel, hård1A Farma A/S
- NetherlandsDimethylfumaraat Abdi 120 mg maagsapresistente capsules, hardAbdi Farma GmbH
- BelgiumDimethyl Fumarate AB 120 mgAurobindo
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Balfumon, Dimethyl Fumarat Zentiva
- Belgium · Dimethyl Fumarate, Dimethyl Fumarate Ab
- Bulgaria · Arbicen, Dimethyl Fumarate Msn
- Cyprus · Dimethyl Fumarate Ebewe, Dimethyl Fumarate Hemopharm
- Czechia · Adifemu, Cohiber
- Germany · Dimethyl Fumarate Piramal, Dimethylfumarat 089pharm
- Denmark · Dimethyl Fumarate 1a Farma, Dimethyl Fumarate G.L. Pharma
- Estonia · Dimethyl Fumarate, Dimethyl Fumarate Aliud
- Spain · Dimforda, Fumarato De Dimetilo Aurovitas
- Finland · Dimethyl Fumarate, Dimethyl Fumarate 1a Farma
- France · Dimethyl Fumarate, Dimethyl Fumarate Arrow
- United Kingdom (Northern Ireland) · Dimethyl Fumarate, Dimethyl Fumarate G.L. Pharma
- Greece · Dimate, Dimethyl Fumarate Aenorasis
- Croatia · Dimethylfumarat Qilu, Dimetilfumarat
- Hungary · Adifemu, Arbicen
- Ireland · Dimethyl Fumarate, Dimethyl Fumarate Clonmel Healthcare
- Iceland · Dimethyl Fumarate, Dimethyl Fumarate 1a Farma
- Italy · Berbira, Dimetilfumarato
- Liechtenstein · Dimethyl Fumarate Accord, Dimethyl Fumarate Mylan
- Lithuania · Arbicen, Cohiber
- Luxembourg · Dimethyl Fumarate Eurogenerics
- Latvia · Cohiber, Dimethyl Fumarate
- Malta · Dimethyl Fumarate Clonmel, Dimethyl Fumarate Clonmel Healthcare
- Netherlands · Dimethyl Fumarate Aurobindo, Dimethylfumaraat Abdi
- Norway · Dimethyl Fumarate 1a Farma, Dimethyl Fumarate Accord
- Poland · Adifemu, Balfumon
- Portugal · Fumarato De Dimetilo Aurobindo, Fumarato De Dimetilo Farmoz
- Romania · Dimethyl Fumarate, Dimetil Fumarat
- Sweden · Dimethyl Fumarate, Dimethyl Fumarate 1a Farma
- Slovenia · Dimethyl Fumarate Msn, Dimetilfumarat Sandoz
- Slovakia · Adifemu, Arbicen
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/c8f061ca-526c-4555-9469-65328db91fd1 GET /v1/drugs/c8f061ca-526c-4555-9469-65328db91fd1?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",
"source": "ndc",
"strength": "240",
"substance": "DIMETHYL FUMARATE",
"productndc": "68462-308",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA210309",
"marketing_category": "ANDA"
}See everything about dimethyl fumarate.
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.