United States· US:0469-1725_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e
Xtandi
A medicinal product containing enzalutamide, registered in United States by Astellas Pharma US, Inc..
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
- enzalutamide
- Manufacturer
- Astellas Pharma US, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 1
- ndc1104691725561 BOTTLE in 1 CARTON (0469-1725-56) / 56 TABLET in 1 BOTTLE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Enzalutamide in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomEnzalutamide 40mg tabletsAstellas Pharma Ltd
- CzechiaENZALUTAMID SANDOZSandoz s.r.o., Praha
- NetherlandsEnzalutamide 1A Pharma 160 mg, filmomhulde tabletten1A Pharma GmbH
- FinlandEnzalutamide 1A Farma1A Farma A/S
- IrelandEnzalutamide Accord 40 mg soft capsulesAccord Healthcare Ireland Ltd.
- SpainENZALUTAMIDA ACCORD 40 MG CAPSULAS BLANDAS EFGAccord Healthcare S.L.U.
- PolandEnzalutamid SandozSandoz Polska Sp. z o.o.
- SwedenEnzalutamide Accordpharma 160 mg Filmdragerad tablettAccord Healthcare S.L.U.
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Englabloc, Enzalutamid 1a Pharma
- Belgium · Enzalutamide Accord, Enzalutamide Eg
- Bulgaria · Ензалутамид Sdz, Ензалутамид Сандоз
- Cyprus · Enzalutamide Accord, Enzalutamide Ebewe
- Czechia · Enzalutamid Sandoz S.R.O., Enzalutamid Stada
- Germany · Enzalutamid Accord, Enzalutamid Al
- Denmark · Enzalutamide "sandoz", Enzalutamide Hexal
- Estonia · Enzalutamide Accord, Enzalutamide Norameda
- Spain · Enzalutamida Accord, Enzalutamida Sandoz
- Finland · Enzalutamide 1a Farma, Enzalutamide Adalvo
- France · Enzalutamide Accord, Enzalutamide Biogaran
- United Kingdom (Northern Ireland) · Enzalutamide Accord Healthcare, Enzalutamide Genus Pharmaceuticals
- Greece · Enzalutamide Accord, Enzalutamide Anabiosis
- Croatia · Enzalutamid Accord, Enzalutamid Pharmascience
- Hungary · Enzalutamid 1 A Pharma, Enzalutamid Sandoz
- Ireland · Enzalutamide Accord, Enzalutamide Clonmel
- Iceland · Enzalutamide Accordpharma, Enzalutamide Hexal
- Italy · Enzalutamide Accord, Enzalutamide Eg
- Liechtenstein · Enzalutamide Accordpharma, Enzalutamide Viatris
- Lithuania · Enzalutamide Accord, Enzalutamide Hexal
- Luxembourg · Enzalutamide Eg
- Latvia · Enzalutamide Accord, Enzalutamide Hexal
- Malta · Enzalutamid Pharos, Enzalutamide
- Netherlands · Enzalutamide 1a Pharma, Enzalutamide Anabiosis
- Norway · Enzalutamide Accord, Enzalutamide Accordpharma
- Poland · Enzalutamid Sandoz, Enzalutamide
- Portugal · Enzalutamida Stada, Enzalutamida Stada 40 Mg Comprimidos Revestidos Por Película
- Romania · Enzalutamidă Accord, Enzalutamida Rhei
- Sweden · Enzalutamid Sun Pharma, Enzalutamide Hexal
- Slovenia · Enzalutamid Sandoz, Enzalutamid Sandoz Gmbh
- Slovakia · Englabloc, Enzalutamid Sandoz
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/d41e5873-5cdc-419a-aa04-65a6a021da95 GET /v1/drugs/d41e5873-5cdc-419a-aa04-65a6a021da95?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",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 5
},
"productid": "0469-1725_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e",
"productndc": "0469-1725",
"dosage_form": "TABLET",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENZALUTAMIDE",
"proprietary_name": "Xtandi",
"active_ingred_unit": "mg/1",
"application_number": "NDA213674",
"marketing_category": "NDA",
"nonproprietary_name": "enzalutamide",
"start_marketing_date": "20200804",
"active_numerator_strength": "40"
}See everything about enzalutamide.
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.