65219-289-65 : NDC 2026 Code

65219-289-65 : Gadobutrol ( Gadobutrol )

Additionally :

You can get information about “65219-289-65” NDC code in 65219-289-65 in HTML format

HTML | 65219-289-65 in TXT (Plain Text) format

TXT | 65219-289-65 in PDF (Portable Document Format)

PDF | 65219-289-65 in XML format

XML formats.

NDC Code : 65219-289-65 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "65219-289-65",
    "PackageDescription": "10 BOTTLE in 1 CARTON (65219-289-65)  / 65 mL in 1 BOTTLE (65219-289-10) ",
    "NDC11Code": "65219-0289-65",
    "ProductNDC": "65219-289",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Gadobutrol",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Gadobutrol",
    "DosageFormName": "INJECTION",
    "RouteName": "INTRAVENOUS",
    "StartMarketingDate": "20231001",
    "EndMarketingDate": null,
    "MarketingCategoryName": "ANDA",
    "ApplicationNumber": "ANDA216081",
    "LabelerName": "Fresenius Kabi USA, LLC",
    "SubstanceName": "GADOBUTROL",
    "StrengthNumber": "604.72",
    "StrengthUnit": "mg/mL",
    "Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2025-11-21",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20231001",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}