United States· US:66658-510_58d52c0a-08fe-40f4-86ba-752dd079ec91
GAMIFANT
A medicinal product containing emapalumab, registered in United States by Swedish Orphan Biovitrum AB (publ).
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
- EMAPALUMAB
- Manufacturer
- Swedish Orphan Biovitrum AB (publ)
- 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
- ndc1166658-510-01
- ndc1166658510011 VIAL, SINGLE-USE in 1 CARTON (66658-510-01) / 20 mL in 1 VIAL, SINGLE-USE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/d8c2d3cf-ae99-4701-b4bd-fe7c31fe0e8b GET /v1/drugs/d8c2d3cf-ae99-4701-b4bd-fe7c31fe0e8b?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": "100",
"substance": "EMAPALUMAB",
"productndc": "66658-510",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/20mL",
"application_number": "BLA761107",
"marketing_category": "BLA"
}See everything about emapalumab.
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.