<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83372-605-01
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (83372-605-01) / 50 mL in 1 VIAL, GLASS (83372-605-02)
</PackageDescription>
<NDC11Code>
83372-0605-01
</NDC11Code>
<ProductNDC>
83372-605
</ProductNDC>
<ProductTypeName>
PLASMA DERIVATIVE
</ProductTypeName>
<ProprietaryName>
Yimmugo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Immune Globulin Intravenous, Human - Dira
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125810
</ApplicationNumber>
<LabelerName>
Biotest AG
</LabelerName>
<SubstanceName>
HUMAN IMMUNOGLOBULIN G
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
g/100mL
</StrengthUnit>
<Pharm_Classes>
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-03-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250301
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>