81927-106-01 : NDC 2026 Code

81927-106-01 : Thiotepa ( Tepylute )

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NDC Code : 81927-106-01 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "81927-106-01",
    "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01)  / 10 mL in 1 VIAL, MULTI-DOSE",
    "NDC11Code": "81927-0106-01",
    "ProductNDC": "81927-106",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Tepylute",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Thiotepa",
    "DosageFormName": "INJECTION",
    "RouteName": "INTRAVENOUS",
    "StartMarketingDate": "20250331",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA216984",
    "LabelerName": "Shorla Oncology Inc.",
    "SubstanceName": "THIOTEPA",
    "StrengthNumber": "10",
    "StrengthUnit": "mg/mL",
    "Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2025-12-23",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20250331",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}