83831-105-01 : NDC 2026 Code

83831-105-01 : Palonosetron ( Posfrea )

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NDC Code : 83831-105-01 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "83831-105-01",
    "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01)  / 5 mL in 1 VIAL, SINGLE-DOSE",
    "NDC11Code": "83831-0105-01",
    "ProductNDC": "83831-105",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Posfrea",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Palonosetron",
    "DosageFormName": "INJECTION, SOLUTION",
    "RouteName": "INTRAVENOUS",
    "StartMarketingDate": "20240930",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA203050",
    "LabelerName": "Avyxa Pharma, LLC",
    "SubstanceName": "PALONOSETRON HYDROCHLORIDE",
    "StrengthNumber": ".25",
    "StrengthUnit": "mg/5mL",
    "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2025-05-01",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20240930",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}