{
"NDC": {
"NDCCode": "85347-001-01",
"PackageDescription": "50 mL in 1 VIAL, GLASS (85347-001-01) ",
"NDC11Code": "85347-0001-01",
"ProductNDC": "85347-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piflufolastat F-18",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Piflufolastat F-18",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260701",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220089",
"LabelerName": "Aphelion LLC",
"SubstanceName": "PIFLUFOLASTAT F-18",
"StrengthNumber": "120",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}