United States· US:54092-700_25f45811-e646-4342-9954-d8220cadf886
ELAPRASE
A idursulfase product containing idursulfase, registered in United States by Takeda Pharmaceuticals America, 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
Idursulfase is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AB09 (idursulfase), 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
Idursulfase · ATC A16AB09
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
- IDURSULFASE
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Country
- United States (US)
- ATC code
- A16AB09
- ATC class
- Idursulfase
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1154092700011 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASS
- ndc1154092-700-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Idursulfase in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaELAPRASETakeda Pharmaceuticals International AG Ireland Branch, Dublin
- CanadaELAPRASETAKEDA CANADA INC
- SwitzerlandElaprase
- SpainELAPRASE 2 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSIONTakeda Pharmaceuticals International Ag Ireland Branch
- FinlandElapraseTakeda Pharmaceuticals International AG Ireland Branch
- FranceELAPRASE 2 mg/ml, solution à diluer pour perfusionTAKEDA PHARMACEUTICALS INTERNATIONAL (IRLANDE)
- United KingdomElaprase 6mg/3ml concentrate for solution for infusion vialsTakeda UK Ltd
- IrelandElaprase 2 mg/ml concentrate for solution for infusionTakeda Pharmaceuticals International AG Ireland Branch
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Elaprase
- Liechtenstein · Elaprase
- Norway · Elaprase
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/e96a0f63-fdac-4a6c-ac28-092bb2126ff3 GET /v1/drugs/e96a0f63-fdac-4a6c-ac28-092bb2126ff3?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": "6",
"substance": "IDURSULFASE",
"productndc": "54092-700",
"dosage_form": "SOLUTION, CONCENTRATE",
"dea_schedule": null,
"strength_unit": "mg/3mL",
"application_number": "BLA125151",
"marketing_category": "BLA"
}See everything about idursulfase.
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.