United States· US:69639-101_4a6ba486-f8be-41a3-847e-429548867605

AKYNZEO

A serotonin (5ht3) antagonists product containing netupitant and palonosetron, registered in United States by Helsinn Therapeutics (U.S.), Inc..

ATC A04AAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Netupitant 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 · 2

ndc11
6963910101
1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK
ndc11
6963910104
2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)

7732P08TIR

NETUPITANT

RxCUI 1552337

Orange Book

N205718

DailyMed SPL labels

1 version tracked

Same class

Other records under A04AA

Serotonin (5ht3) antagonists, as other registers publish it.

All netupitant and palonosetron products

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/169aa760-6999-4251-a8e3-90b18bce3c01
GET /v1/drugs/169aa760-6999-4251-a8e3-90b18bce3c01?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": "7732P08TIR",
    "rxcui": "1552337",
    "inchikey": "WAXQNWCZJDTGBU-UHFFFAOYSA-N",
    "display_name": "NETUPITANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "69639-101_4a6ba486-f8be-41a3-847e-429548867605",
  "productndc": "69639-101",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205718",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 10, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NETUPITANT; PALONOSETRON",
  "proprietary_name": "AKYNZEO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205718",
  "marketing_category": "NDA",
  "nonproprietary_name": "Netupitant and Palonosetron",
  "start_marketing_date": "20141013",
  "active_numerator_strength": "300; .5"
}

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