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United States· US:71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139

Galafold

A migalastat product containing migalastat hydrochloride, registered in United States by Amicus Therapeutics US, LLC. The same ATC class is registered in 16 of our 19 countries.

ATC A16AX14US 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…normalisedGalafoldATCA16AX14REGISTER NO.US:71904-100_2da6bbb5…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about migalastat hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Migalastat is registered in 16 of 19 countries.

Countries holding a registration under ATC A16AX14 (migalastat), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 11 of them publish a price we can compare per daily dose
Search migalastat products by name

Migalastat · ATC A16AX14

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of migalastat costs, country by country.

Normalised to the WHO defined daily dose (61.5 mg), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Migalastat · price per daily dose (61.5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$793.74
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
MIGALASTAT HYDROCHLORIDE
Manufacturer
Amicus Therapeutics US, LLC
Country
United States (US)
ATC code
A16AX14
ATC class
Migalastat
Defined daily dose
61.5 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    71904-100-01
  • ndc11
    7190410001
    14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK

Regulatory notes

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

Interactions

1 interaction on record for migalastat.

Graded by severity as the source publishes them — 1 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check migalastat against other medicinesHow interaction checks work

Migalastat · interactions on record

1 record

  • 1 moderate

Most severe, free to view

  • Agalsidase betaA16AB04moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Migalastat in 15 other countries

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

All migalastat products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Galafold
  • Liechtenstein · Galafold
  • Norway · Galafold

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/b5d084c2-667d-41fc-bfe1-69b22034eec4
GET /v1/drugs/b5d084c2-667d-41fc-bfe1-69b22034eec4?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": "123",
  "substance": "MIGALASTAT HYDROCHLORIDE",
  "productndc": "71904-100",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA208623",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about migalastat.

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.

Try it freeOpen in the console