{
"NDC": {
"NDCCode": "67184-0611-2",
"PackageDescription": "10 VIAL in 1 CARTON (67184-0611-2) / 10 mL in 1 VIAL (67184-0611-1) ",
"NDC11Code": "67184-0611-02",
"ProductNDC": "67184-0611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251028",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219608",
"LabelerName": "Qilu Pharmaceutical Co., Ltd.",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"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": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}