{
"NDC": {
"NDCCode": "0054-0975-80",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0054-0975-80) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00054-0975-80",
"ProductNDC": "0054-0975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Hydrocortisone",
"ProprietaryNameSuffix": "Otic",
"NonProprietaryName": "Neomycin And Polymyxin B Sulfates And Hydrocortisone",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20261008",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220938",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE",
"StrengthNumber": "3.5; 10000; 10",
"StrengthUnit": "mg/mL; [iU]/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261008",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}