81583-100-01 : NDC 2026 Code

81583-100-01 : Ganaxolone ( Ztalmy )

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NDC Code : 81583-100-01 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "81583-100-01",
    "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01)  / 110 mL in 1 BOTTLE, PLASTIC",
    "NDC11Code": "81583-0100-01",
    "ProductNDC": "81583-100",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Ztalmy",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Ganaxolone",
    "DosageFormName": "SUSPENSION",
    "RouteName": "ORAL",
    "StartMarketingDate": "20220606",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA215904",
    "LabelerName": "Immedica Pharma US Inc",
    "SubstanceName": "GANAXOLONE",
    "StrengthNumber": "50",
    "StrengthUnit": "mg/mL",
    "Pharm_Classes": "GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
    "DEASchedule": "CV",
    "Status": "Active",
    "LastUpdate": "2025-12-01",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20220606",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}