65219-643-03 : NDC 2026 Code

65219-643-03 : Amiodarone Hydrochloride ( Amiodarone Hydrochloride )

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NDC Code : 65219-643-03 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "65219-643-03",
    "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-643-03)  / 3 mL in 1 VIAL, SINGLE-DOSE (65219-643-01) ",
    "NDC11Code": "65219-0643-03",
    "ProductNDC": "65219-643",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Amiodarone Hydrochloride",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Amiodarone Hydrochloride",
    "DosageFormName": "INJECTION, SOLUTION",
    "RouteName": "INTRAVENOUS",
    "StartMarketingDate": "20250505",
    "EndMarketingDate": null,
    "MarketingCategoryName": "ANDA",
    "ApplicationNumber": "ANDA075761",
    "LabelerName": "Fresenius Kabi USA, LLC",
    "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": "2025-05-05",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20250505",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}