{
"NDC": {
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"PackageDescription": "12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01) ",
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"ProductNDC": "59353-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Korsuva",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Difelikefalin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211101",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214916",
"LabelerName": "Vifor (International), Inc.",
"SubstanceName": "DIFELIKEFALIN ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Kappa Opioid Receptor Agonist [EPC], Opioid kappa Receptor Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211101",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}