United States· US:58468-0050_ce8d4153-ce95-43c4-9672-e1e951ebcdaa
XENPOZYME
A olipudase alfa product containing olipudase alfa, registered in United States by Genzyme Corporation. 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
Olipudase alfa is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AB25 (olipudase alfa), 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
Olipudase alfa · ATC A16AB25
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
- OLIPUDASE ALFA
- Manufacturer
- Genzyme Corporation
- Country
- United States (US)
- ATC code
- A16AB25
- ATC class
- Olipudase alfa
- Defined daily dose
- 15 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
- ndc1158468005011 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL
- ndc1158468-0050-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Olipudase alfa in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaXENPOZYMESanofi B.V., Amsterdam
- SwitzerlandXenpozyme 20 mg, poudre pour solution à diluer pour perfusionSanofi-Aventis (Suisse) SA
- PolandXenpozymeSanofi B.V.
- SwedenXenpozyme 20 mg Pulver till koncentrat till infusionsvätska, lösningSanofi B.V.
- BelgiumXenpozyme 20 mgSanofi
- SpainXENPOZYME 20 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONSanofi B.V.
- FinlandXenpozymeSanofi B.V.
- NetherlandsXenpozyme 20 mg, poeder voor concentraat voor oplossing voor infusieGenzyme Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Xenpozyme
- Liechtenstein · Xenpozyme
- Norway · Xenpozyme
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/a0f50424-3d24-4b69-bc88-0be0a244e41c GET /v1/drugs/a0f50424-3d24-4b69-bc88-0be0a244e41c?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": "20",
"substance": "OLIPUDASE ALFA",
"productndc": "58468-0050",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/5.1mL",
"application_number": "BLA761261",
"marketing_category": "BLA"
}See everything about olipudase alfa.
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.