United States· US:68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363
NAGLAZYME
A galsulfase product containing galsulfase, registered in United States by BioMarin Pharmaceutical Inc.. The same ATC class is registered in 14 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Galsulfase is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AB08 (galsulfase), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 9 of them publish a price we can compare per daily dose
Galsulfase · ATC A16AB08
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- GALSULFASE
- Manufacturer
- BioMarin Pharmaceutical Inc.
- Country
- United States (US)
- ATC code
- A16AB08
- ATC class
- Galsulfase
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168135020011 VIAL in 1 CARTON (68135-020-01) / 5 mL in 1 VIAL
- ndc1168135-020-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Galsulfase in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaNAGLAZYMEBioMarin International Limited, Dublin
- CanadaNAGLAZYMEBIOMARIN PHARMACEUTICAL INC.
- SwitzerlandNaglazyme, Konzentrat zur Herstellung einer InfusionslösungDRAC AG
- SpainNAGLAZYME 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONBiomarin International Limited
- FinlandNaglazymeBiomarin International Limited
- FranceNAGLAZYME 1 mg/ml, solution à diluer pour perfusionBIOMARIN INTERNATIONAL LIMITED (IRLANDE)
- United KingdomNaglazyme 5mg/5ml solution for infusion vialsBioMarin (U.K.) Ltd
- IrelandNaglazyme 1 mg/ml concentrate for solution for infusionBioMarin International Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Naglazyme
- Liechtenstein · Naglazyme
- Norway · Naglazyme
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/2193c539-b32e-47ba-bef6-19a6108b2fbf GET /v1/drugs/2193c539-b32e-47ba-bef6-19a6108b2fbf?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": "INTRAVENOUS",
"source": "ndc",
"strength": "5",
"substance": "GALSULFASE",
"productndc": "68135-020",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/5mL",
"application_number": "BLA125117",
"marketing_category": "BLA"
}See everything about galsulfase.
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.