{
"NDC": {
"NDCCode": "44523-055-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01) ",
"NDC11Code": "44523-0055-01",
"ProductNDC": "44523-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiopronin",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Tiopronin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241205",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA211843",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "TIOPRONIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241205",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}