United States· US:69639-106_4a6ba486-f8be-41a3-847e-429548867605
AKYNZEO
A serotonin (5ht3) antagonists product containing fosnetupitant and 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
- Fosnetupitant and Palonosetron
- Manufacturer
- Helsinn Therapeutics (U.S.), Inc.
- Country
- United States (US)
- ATC code
- A04AA
- ATC class
- Serotonin (5HT3) antagonists
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 1
- ndc1169639106011 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Regulatory notes
Same class
Other records under A04AA
Serotonin (5ht3) antagonists, as other registers publish it.
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/68e9e282-6553-4e21-aec2-39a4f5b7f4b5 GET /v1/drugs/68e9e282-6553-4e21-aec2-39a4f5b7f4b5?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.
{
"unii": {
"unii": "T672P80L2S",
"rxcui": "2044417",
"inchikey": "HZIYEEMJNBKMJH-UHFFFAOYSA-N",
"display_name": "FOSNETUPITANT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"8e47618e-af46-4d82-94e8-1507c042252d": {
"match": "brand_token",
"title": "AKYNZEO (NETUPITANT AND PALONOSETRON) CAPSULE AKYNZEO (FOSNETUPITANT AND PALONOSETRON) INJECTION [HELSINN THERAPEUTICS (U.S.), INC.]",
"spl_version": "18",
"published_date": "2026-01-28"
}
},
"productid": "69639-106_4a6ba486-f8be-41a3-847e-429548867605",
"productndc": "69639-106",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210493",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL",
"product_no": "001",
"approval_date": "Apr 19, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)",
"product_no": "002",
"approval_date": "May 27, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE",
"proprietary_name": "AKYNZEO",
"active_ingred_unit": "mg/20mL; mg/20mL",
"application_number": "NDA210493",
"marketing_category": "NDA",
"nonproprietary_name": "Fosnetupitant and Palonosetron",
"start_marketing_date": "20230801",
"active_numerator_strength": "260; .28"
}See everything about fosnetupitant and 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.