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United States· US:70771-1531_d8dceb92-b903-4b29-b3e6-4651fbc598fe

dimethyl fumarate

A medicinal product containing dimethyl fumarate, registered in United States by Zydus Lifesciences Limited.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normaliseddimethyl fumarateATC—REGISTER NO.US:70771-1531_d8dceb9…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DIMETHYL FUMARATE
Manufacturer
Zydus Lifesciences Limited
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 · 4

  • ndc11
    7077115316
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-6)
  • ndc11
    7077115318
    46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-8)
  • ndc11
    70771-1531-6
  • ndc11
    70771-1531-8

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.

All dimethyl fumarate products

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/7ce30073-242f-423d-bebe-cb33da13ce33
GET /v1/drugs/7ce30073-242f-423d-bebe-cb33da13ce33?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": "70771-1531",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA210538",
  "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.