🇺🇸
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
- ndc1169639105011 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
Other records sharing ATC code A04AA.
- 🇺🇸AKYNZEOHelsinn Therapeutics (U.S.), Inc.
- 🇺🇸AKYNZEOHelsinn Therapeutics (U.S.), Inc.
- 🇺🇸AKYNZEOHelsinn Therapeutics (U.S.), Inc.
- 🇪🇸AKYNZEO 235 MG/0,25 MG POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓNHelsinn Birex Pharmaceuticals Limited
- 🇪🇸AKYNZEO 300 MG/0,5 MG CAPSULAS DURASHelsinn Birex Pharmaceuticals Limited
- 🇫🇷AKYNZEO 300 mg/0,5 mg, gélulesHELSINN BIREX PHARMACEUTICALS
- GBAkynzeo 300mg/0.5mg capsulesChugai Pharma UK Ltd
- 🇪🇸ONDANSETRÓN SERRACLINICS 2 MG/ML SOLUCIÓN INYECTABLE EFGLaboratorios Serra Pamies S.A.
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