<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70461-555-10
</NDCCode>
<PackageDescription>
1 VIAL, MULTI-DOSE in 1 CARTON (70461-555-10) / 5 mL in 1 VIAL, MULTI-DOSE (70461-555-11)
</PackageDescription>
<NDC11Code>
70461-0555-10
</NDC11Code>
<ProductNDC>
70461-555
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Flucelvax
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/victoria/800/2024 Cvr-289 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated),influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated)
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20250701
</StartMarketingDate>
<EndMarketingDate>
20260731
</EndMarketingDate>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125408
</ApplicationNumber>
<LabelerName>
Seqirus Inc.
</LabelerName>
<SubstanceName>
INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
</SubstanceName>
<StrengthNumber>
15; 15; 15
</StrengthNumber>
<StrengthUnit>
ug/.5mL; ug/.5mL; ug/.5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20250701
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260731
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>