84577-751-01 : NDC 2026 Code

84577-751-01 : Gedatolisib ( Revtorpyk )

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NDC Code : 84577-751-01 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "84577-751-01",
    "PackageDescription": "1 VIAL, GLASS in 1 CARTON (84577-751-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
    "NDC11Code": "84577-0751-01",
    "ProductNDC": "84577-751",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Revtorpyk",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Gedatolisib",
    "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
    "RouteName": "INTRAVENOUS",
    "StartMarketingDate": "20260930",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA219908",
    "LabelerName": "Celcuity Inc.",
    "SubstanceName": "GEDATOLISIB",
    "StrengthNumber": "180",
    "StrengthUnit": "mg/1",
    "Pharm_Classes": "Kinase Inhibitor [EPC], Phosphoinositide 3-Kinases Inhibitors [MoA], mTOR Inhibitors [MoA]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2026-10-01",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20271231",
    "StartMarketingDatePackage": "20260930",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}