58468-0347-1 : NDC 2025 Code

58468-0347-1 : Fitusiran ( Qfitlia )

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NDC Code : 58468-0347-1 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "58468-0347-1",
    "PackageDescription": "1 VIAL in 1 CARTON (58468-0347-1)  / .2 mL in 1 VIAL",
    "NDC11Code": "58468-0347-01",
    "ProductNDC": "58468-0347",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Qfitlia",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Fitusiran",
    "DosageFormName": "INJECTION, SOLUTION",
    "RouteName": "SUBCUTANEOUS",
    "StartMarketingDate": "20250328",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA219019",
    "LabelerName": "Genzyme Corporation",
    "SubstanceName": "FITUSIRAN",
    "StrengthNumber": "20",
    "StrengthUnit": "mg/.2mL",
    "Pharm_Classes": "Antithrombin-directed RNA Interaction [EPC], Decreased RNA Integrity [PE], Increased RNA Degradation [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2025-09-17",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20250328",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}