{
"NDC": {
"NDCCode": "80978-106-01",
"PackageDescription": "10 mL in 1 VIAL (80978-106-01) ",
"NDC11Code": "80978-0106-01",
"ProductNDC": "80978-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tepylute",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Thiotepa",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250321",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216984",
"LabelerName": "Aqvida GmBH",
"SubstanceName": "THIOTEPA",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"DEASchedule": null,
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250321",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}