{
"NDC": {
"NDCCode": "70518-1231-1",
"PackageDescription": "25 VIAL in 1 BOX (70518-1231-1) / 3 mL in 1 VIAL (70518-1231-0) ",
"NDC11Code": "70518-1231-01",
"ProductNDC": "70518-1231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180530",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077234",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180530",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}