<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58160-826-52
</NDCCode>
<PackageDescription>
10 SYRINGE in 1 CARTON (58160-826-52) / 1 mL in 1 SYRINGE (58160-826-43)
</PackageDescription>
<NDC11Code>
58160-0826-52
</NDC11Code>
<ProductNDC>
58160-826
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Havrix
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hepatitis A Vaccine
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20070413
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA103475
</ApplicationNumber>
<LabelerName>
GlaxoSmithKline Biologicals SA
</LabelerName>
<SubstanceName>
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
</SubstanceName>
<StrengthNumber>
1440
</StrengthNumber>
<StrengthUnit>
[iU]/mL
</StrengthUnit>
<Pharm_Classes>
Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-02-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20070413
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>