United States· US:0078-1483_9e44a793-9940-4ae3-9fe6-0f901afa37e0
RHAPSIDO
A remibrutinib product containing remibrutinib, registered in United States by Novartis Pharmaceuticals Corporation. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Remibrutinib is registered in 9 of 19 countries.
Countries holding a registration under ATC L04AA60 (remibrutinib), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Remibrutinib · ATC L04AA60
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- REMIBRUTINIB
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Country
- United States (US)
- ATC code
- L04AA60
- ATC class
- Remibrutinib
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc11007814832060 TABLET in 1 BOTTLE (0078-1483-20)
- ndc1100781483922 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE
- ndc11007814839330 TABLET in 1 BOTTLE (0078-1483-93)
- ndc110078-1483-20
- ndc110078-1483-92
- ndc110078-1483-93
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Remibrutinib in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaRHAPSIDONovartis Europharm Limited, Dublin
- SwitzerlandRhapsido, FilmtablettenNovartis Pharma Schweiz AG
- SpainRHAPSIDO 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULANovartis Europharm Limited
- FinlandRhapsidoNovartis Europharm Limited
- IrelandRhapsido 25 mg film-coated tabletsNovartis Europharm Limited
- IcelandRhapsidoNovartis Europharm Limited*
- NetherlandsRhapsido 25 mg filmomhulde tablettenNovartis Europharm Limited
- PolandRhapsidoNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Rhapsido
- Liechtenstein · Rhapsido
- Norway · Rhapsido
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/e70a04e5-ba0c-4d3f-8627-e906e2642b1d GET /v1/drugs/e70a04e5-ba0c-4d3f-8627-e906e2642b1d?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",
"source": "ndc",
"strength": "25",
"substance": "REMIBRUTINIB",
"productndc": "0078-1483",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA218436",
"marketing_category": "NDA"
}See everything about remibrutinib.
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.