{
"NDC": {
"NDCCode": "65219-818-13",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03) ",
"NDC11Code": "65219-0818-13",
"ProductNDC": "65219-818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240911",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217548",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}