{
"NDC": {
"NDCCode": "63552-722-10",
"PackageDescription": "5 SYRINGE, GLASS in 1 PACKAGE (63552-722-10) / .5 mL in 1 SYRINGE, GLASS (63552-722-05) ",
"NDC11Code": "63552-0722-10",
"ProductNDC": "63552-722",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone High Dose Northern Hemisphere",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250901",
"EndMarketingDate": null,
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Patheon Manufacturing Services LLC",
"SubstanceName": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "60; 60; 60",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": null,
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}