<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
49281-126-65
</NDCCode>
<PackageDescription>
5 SYRINGE, GLASS in 1 PACKAGE (49281-126-65) / .5 mL in 1 SYRINGE, GLASS (49281-126-88)
</PackageDescription>
<NDC11Code>
49281-0126-65
</NDC11Code>
<ProductNDC>
49281-126
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Fluzone High Dose Northern Hemisphere
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Influenza A Virus A/switzerland/6849/2025 Ivr-278 (a/missouri/11/2025 Pdm09-like Virus) (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/michigan/105/2025 San-049a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/tokyo/eis13-175/2025 Antigen (formaldehyde Inactivated)
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20260702
</StartMarketingDate>
<EndMarketingDate>
20270630
</EndMarketingDate>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA103914
</ApplicationNumber>
<LabelerName>
Sanofi Vaccines US Inc.
</LabelerName>
<SubstanceName>
INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
</SubstanceName>
<StrengthNumber>
60; 60; 60
</StrengthNumber>
<StrengthUnit>
ug/.5mL; ug/.5mL; ug/.5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20260702
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20270630
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>