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United States · US · US:69639-105_4a6ba486-f8be-41a3-847e-429548867605

AKYNZEO

Orange BookUNIISPLATC A04AA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHelsinn Therapeutics (U.S.), Inc.
CountryUS (United States)
ATC codeA04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6963910501
    1 VIAL in 1 CARTON (69639-105-01) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
T672P80L2S
FOSNETUPITANT
RxCUI 2044417
Orange Book
N210493
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "69639-105_4a6ba486-f8be-41a3-847e-429548867605",
  "productndc": "69639-105",
  "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": "20200615",
  "active_numerator_strength": "260; .28"
}

Related drugs

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