United States· US:50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4
Xofigo
A medicinal product containing radium ra-223 dichloride, registered in United States by Bayer HealthCare Pharmaceuticals 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
- RADIUM RA-223 DICHLORIDE
- Manufacturer
- Bayer HealthCare Pharmaceuticals 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 27, 2026
Packs & prices · 2
- ndc1150419208016 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)
- ndc1150419-208-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Radium ra-223 dichloride in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumXofigo 1100 kBq/mlBayer
- CanadaXOFIGOBAYER INC
- United KingdomXofigo [Ra-223] 6.6MBq/6ml solution for injection vialsBayer Plc
- IrelandXofigo 1100 kBq/mL solution for injectionBayer AG
- NorwayXofigoBayer AG
- SwedenXofigo 1100 kBq/ml Injektionsvätska, lösningBayer AG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Xofigo
- Liechtenstein · Xofigo
- Norway · Xofigo
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/9706eefb-ac26-45f4-bbed-e5b27759e94a GET /v1/drugs/9706eefb-ac26-45f4-bbed-e5b27759e94a?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": "30",
"substance": "RADIUM RA-223 DICHLORIDE",
"productndc": "50419-208",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "uCi/mL",
"application_number": "NDA203971",
"marketing_category": "NDA"
}See everything about radium ra-223 dichloride.
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.