<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50090-1645-0
</NDCCode>
<PackageDescription>
10 SYRINGE in 1 CARTON (50090-1645-0) / 1 mL in 1 SYRINGE (50090-1645-9)
</PackageDescription>
<NDC11Code>
50090-1645-00
</NDC11Code>
<ProductNDC>
50090-1645
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Twinrix
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hepatitis A And Hepatitis B (recombinant) Vaccine
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20070607
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA103850
</ApplicationNumber>
<LabelerName>
A-S Medication Solutions
</LabelerName>
<SubstanceName>
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
</SubstanceName>
<StrengthNumber>
720; 20
</StrengthNumber>
<StrengthUnit>
[iU]/mL; ug/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>
2023-12-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20070607
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>