United States· US:42571-275_3afc3c42-1157-b612-e063-6294a90ac179

DALFAMPRIDINE

A medicinal product containing dalfampridine, registered in United States by Micro Labs 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…normalisedDALFAMPRIDINEATC—REGISTER NO.US:42571-275_3afc3c42…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DALFAMPRIDINE
Manufacturer
Micro Labs 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 · 6

  • ndc11
    42571-275-10
  • ndc11
    42571-275-60
  • ndc11
    4257127505
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)
  • ndc11
    4257127510
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)
  • ndc11
    4257127560
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)
  • ndc11
    42571-275-05

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Dalfampridine in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All dalfampridine products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Fampridin Neuraxpharm, Fampridin Ratiopharm
  • Cyprus · Fampridine Sandoz, Fampridine Viatris
  • Czechia · Fampridin Sandoz, Fampridine Abdi
  • Germany · Fampridin Abdi, Fampridin Abz
  • Denmark · Fampridin "neuraxpharm", Fampridin Medical Valley
  • Spain · Fampridina Aurovitas, Fampridina Qualigen
  • Finland · Fampridin Medical Valley, Fampridin Zentiva
  • France · Fampridine Arrow, Fampridine Eg
  • United Kingdom (Northern Ireland) · Elupria, Fampridine Abdi
  • Greece · Fadisa, Fampridine Sandoz
  • Croatia · Fampridin Sandoz, Fampridin Teva
  • Hungary · Fampridine Rontis
  • Ireland · Fampridine Rowa
  • Iceland · Fampridin Medical Valley, Fampridin Neuraxpharm
  • Italy · Fampridina Abdi
  • Liechtenstein · Fampridine Accord, Fampyra
  • Luxembourg · Fampridine Eg
  • Malta · Fampridine Viatris
  • Netherlands · Fampridine Abdi, Fampridine Ascend
  • Norway · Fampridin Medical Valley, Fampridin Neuraxpharm
  • Poland · Fampridine Sandoz, Fampridine Teva
  • Portugal · Fampridina Ascend, Fampridina Generis
  • Sweden · Fampridin Medical Valley, Fampridin Zentiva
  • Slovenia · Fampridin Stada, Fampridin Teva
  • Slovakia · Fampridín Teva, Fampridine Sandoz

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/c3b82881-a23a-4e53-8965-eff16f533d44
GET /v1/drugs/c3b82881-a23a-4e53-8965-eff16f533d44?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": "10",
  "substance": "DALFAMPRIDINE",
  "productndc": "42571-275",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA210158",
  "marketing_category": "ANDA"
}

See everything about dalfampridine.

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.