<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
33332-125-10
</NDCCode>
<PackageDescription>
1 VIAL, MULTI-DOSE in 1 CARTON (33332-125-10) / 5 mL in 1 VIAL, MULTI-DOSE (33332-125-11)
</PackageDescription>
<NDC11Code>
33332-0125-10
</NDC11Code>
<ProductNDC>
33332-125
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Afluria
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated)
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20250701
</StartMarketingDate>
<EndMarketingDate>
20260731
</EndMarketingDate>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125254
</ApplicationNumber>
<LabelerName>
Seqirus PTY LTD.
</LabelerName>
<SubstanceName>
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (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>