United States· US:58468-0070_c37ec1bf-5497-45ca-a204-915b91bff0f6
ALDURAZYME
A medicinal product containing laronidase, registered in United States by Genzyme Corporation.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LARONIDASE
- Manufacturer
- Genzyme Corporation
- 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 · 1
- ndc1158468-0070-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Laronidase in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaALDURAZYMESanofi B.V., Amsterdam
- FinlandAldurazymeOrifarm Oy
- FranceALDURAZYME 100 U/ml, solution à diluer pour perfusionSANOFI (PAYS-BAS)
- United KingdomAldurazyme 500units/5ml concentrate for solution for infusion vialsSanofi
- BelgiumAldurazyme 100 U/mlSanofi
- IcelandAldurazymeGenzyme Europe B.V.
- Japanラロニダーゼ（遺伝子組換え）サノフィ
- NetherlandsAldurazyme, concentraat voor oplossing voor i.v. infusie, 100U/ml, 5 mlGenzyme Europe BV
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Aldurazyme
- Liechtenstein · Aldurazyme
- Norway · Aldurazyme
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/9c275357-217c-459f-8e51-c377318bfa6e GET /v1/drugs/9c275357-217c-459f-8e51-c377318bfa6e?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": "2.9",
"substance": "LARONIDASE",
"productndc": "58468-0070",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"dea_schedule": null,
"strength_unit": "mg/5mL",
"application_number": "BLA125058",
"marketing_category": "BLA"
}See everything about laronidase.
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.