{
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"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9815-03",
"ProductNDC": "0404-9815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220108",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076217",
"LabelerName": "Henry Schein, 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": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": null,
"StartMarketingDatePackage": "20220108",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N"
}
}