<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50090-3469-0
</NDCCode>
<PackageDescription>
5 VIAL in 1 CARTON (50090-3469-0) > .5 mL in 1 VIAL (50090-3469-9)
</PackageDescription>
<NDC11Code>
50090-3469-00
</NDC11Code>
<ProductNDC>
50090-3469
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Heplisav-b
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hepatitis B Vaccine (recombinant) Adjuvanted
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20180101
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125428
</ApplicationNumber>
<LabelerName>
A-S Medication Solutions
</LabelerName>
<SubstanceName>
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
ug/.5mL
</StrengthUnit>
<Pharm_Classes>
Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2020-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20180101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>