United States· US:57894-801_38376edc-230b-4b2b-8bb6-55b9dccea7a5
IMAAVY
A nipocalimab product containing nipocalimab, registered in United States by Janssen Biotech, Inc.. The same ATC class is registered in 8 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Nipocalimab is registered in 8 of 19 countries.
Countries holding a registration under ATC L04AL03 (nipocalimab), 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
Nipocalimab · ATC L04AL03
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- NIPOCALIMAB
- Manufacturer
- Janssen Biotech, Inc.
- Country
- United States (US)
- ATC code
- L04AL03
- ATC class
- Nipocalimab
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1157894-801-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nipocalimab in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaIMAAVYJanssen-Cilag International N.V., Beerse
- BelgiumImaavy 185 mg/mlJanssen-Cilag International
- IrelandImaavy 185 mg/mL concentrate for solution for infusionJanssen-Cilag International NV
- IcelandIMAAVYJanssen Cilag International
- PolandImaavyJanssen-Cilag International N.V.
- SwedenImaavy 185 mg/ml Koncentrat till infusionsvätska, lösningJanssen-Cilag International NV
- FinlandImaavyJanssen Cilag International
- SwitzerlandImaavy 1200 mg/6.5 ml (185 mg/ml), Konzentrat zur Herstellung einer InfusionslösungJanssen-Cilag AG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Imaavy
- Liechtenstein · Imaavy
- Norway · Imaavy
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/3b1c5198-3030-4481-8415-9733ec130dce GET /v1/drugs/3b1c5198-3030-4481-8415-9733ec130dce?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": "185",
"substance": "NIPOCALIMAB",
"productndc": "57894-801",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "BLA761430",
"marketing_category": "BLA"
}See everything about nipocalimab.
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.