United States· US:69639-101_c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1
AKYNZEO
A medicinal product containing netupitant; palonosetron, registered in United States by Helsinn Therapeutics (U.S.), 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
- NETUPITANT; PALONOSETRON
- Manufacturer
- Helsinn Therapeutics (U.S.), 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
- ndc1169639-101-01
- ndc1169639-101-04
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Netupitant; palonosetron in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAKYNZEOHelsinn Birex Pharmaceuticals Ltd., Dublin
- CanadaAKYNZEOKNIGHT THERAPEUTICS INC.
- PolandAkynzeoHelsinn Birex Pharmaceuticals Ltd.
- IcelandAkynzeoHelsinn Birex Pharmaceuticals Ltd.*
- FinlandAkynzeoHelsinn Birex Pharmaceuticals Ltd
- NetherlandsAkynzeo 300 mg/0,5 mg harde capsulesHelsinn Birex Pharmaceuticals Limited
- SpainAKYNZEO 300 MG/0,5 MG CAPSULAS DURASHelsinn Birex Pharmaceuticals Limited
- FranceAKYNZEO 300 mg/0,5 mg, gélulesHELSINN BIREX PHARMACEUTICALS
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Akynzeo
- Liechtenstein · Akynzeo
- Norway · Akynzeo
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/1a780b41-9f95-4dc9-839b-84dcbefa0da4 GET /v1/drugs/1a780b41-9f95-4dc9-839b-84dcbefa0da4?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": "300; .5",
"substance": "NETUPITANT; PALONOSETRON",
"productndc": "69639-101",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA205718",
"marketing_category": "NDA"
}See everything about netupitant; palonosetron.
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.