🇺🇸
United States · US · US:0781-3415_f160a215-5fc0-41bc-9dfb-9dee7ef62388
Palonosetron Hydrochloride
In shortageOrange BookUNIISPLATC A04AA55
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA04AA55
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1107813415751 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75) / 5 mL in 1 VIAL, SINGLE-DOSE
- ndc11078134159510 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-95) / 5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
23310D4I19
PALONOSETRON HYDROCHLORIDE
RxCUI 397405
Orange Book
A202521
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Palonosetron Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "23310D4I19",
"rxcui": "397405",
"inchikey": "OLDRWYVIKMSFFB-SSPJITILSA-N",
"display_name": "PALONOSETRON HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"911783eb-91a8-4ef4-bd6f-809211e207d6": {
"match": "brand_token",
"title": "PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]",
"spl_version": "9",
"published_date": "2026-03-30"
}
},
"productid": "0781-3415_f160a215-5fc0-41bc-9dfb-9dee7ef62388",
"productndc": "0781-3415",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "202521",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)",
"product_no": "001",
"approval_date": "Oct 13, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PALONOSETRON HYDROCHLORIDE",
"shortage_reason": "Palonosetron Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Palonosetron Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA202521",
"marketing_category": "ANDA",
"nonproprietary_name": "Palonosetron Hydrochloride",
"start_marketing_date": "20180323",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code A04AA55.
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- ISAkynzeoHelsinn Birex Pharmaceuticals Ltd.*
- ISAkynzeoHelsinn Birex Pharmaceuticals Ltd.*
- ISAkynzeoHelsinn Birex Pharmaceuticals Ltd.*
- PLAkynzeoHelsinn Birex Pharmaceuticals Ltd.
- ISAkynzeoHelsinn Birex Pharmaceuticals Ltd.*
- PLAkynzeoHelsinn Birex Pharmaceuticals Ltd.
Access this data programmatically
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