United States· US:71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540
OPFOLDA
A miglustat product containing miglustat, registered in United States by AMICUS THERAPEUTICS US, LLC. The same ATC class is registered in 18 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Miglustat is registered in 18 of 19 countries.
Countries holding a registration under ATC A16AX06 (miglustat), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 10 of them publish a price we can compare per daily dose
Miglustat · ATC A16AX06
18 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of miglustat costs, country by country.
Normalised to the WHO defined daily dose (0.3 g), 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
Miglustat · price per daily dose (0.3 g)
USD · FX 28 Sept 2026
- CH Switzerland$225.28
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MIGLUSTAT
- Manufacturer
- AMICUS THERAPEUTICS US, LLC
- Country
- United States (US)
- ATC code
- A16AX06
- ATC class
- Miglustat
- Defined daily dose
- 0.3 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1171904-300-01
- ndc1171904-300-02
- ndc1171904-300-03
- ndc1171904300014 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC
- ndc11719043000224 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC
- ndc117190430003100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
1 interaction on record for miglustat.
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
Miglustat · interactions on record
1 record
- 1 moderate
Most severe, free to view
- ImigluceraseA16AB02moderate
- 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.
Same medicine, other countries
Miglustat in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandOpfolda 65 mg, HartkapselnAmicus Therapeutics Switzerland GmbH
- CzechiaOPFOLDAAmicus Therapeutics Europe Limited, Dublin
- FinlandOpfoldaAmicus Therapeutics Europe Limited
- FranceOPFOLDA 65 mg, géluleAMICUS THERAPEUTICS EUROPE (IRLANDE)
- United KingdomOpfolda 65mg capsulesAmicus Therapeutics UK Operations Ltd
- IrelandOpfolda 65 mg hard capsulesAmicus Therapeutics Europe Limited
- IcelandOpfoldaAmicus Therapeutics Europe Limited*
- NetherlandsOpfolda 65 mg harde capsulesAmicus Therapeutics Europe Limited
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Austria · Miglustat G.L.
- Bulgaria · Миглустат G.L.
- Cyprus · Miglustat Accord
- Czechia · Miglustat Accord
- Germany · Miglustat Accord, Miglustat Axunio
- Denmark · Miglustat Bluefish, Miglustat Waymade
- Spain · Miglustat Accord, Miglustat Waymade
- Finland · Miglustat Accord, Miglustat Waymade
- France · Miglustat Accord, Miglustat Bluefish
- United Kingdom (Northern Ireland) · Miglustat Accord Healthcare, Miglustat Dipharma
- Iceland · Miglustat Dipharma, Opfolda
- Italy · Miglustat Accord, Miglustat Waymade
- Liechtenstein · Miglustat Dipharma, Opfolda
- Netherlands · Miglustat G.L., Miglustat Waymade
- Norway · Miglustat Bluefish, Miglustat Dipharma
- Poland · Miglustat, Miglustat Accord
- Portugal · Miglustato Accord
- Romania · Miglustat Accord
- Sweden · Miglustat, Miglustat Bluefish
- Slovakia · Miglustat Accord, Miglustat G.L. Pharma
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/db79fa6a-63f1-45f9-81a4-eff1bd82e51b GET /v1/drugs/db79fa6a-63f1-45f9-81a4-eff1bd82e51b?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": "65",
"substance": "MIGLUSTAT",
"productndc": "71904-300",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA215211",
"marketing_category": "NDA"
}See everything about miglustat.
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.