<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63833-892-51
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (63833-892-51) / 100 mL in 1 VIAL, GLASS (63833-892-90)
</PackageDescription>
<NDC11Code>
63833-0892-51
</NDC11Code>
<ProductNDC>
63833-892
</ProductNDC>
<ProductTypeName>
PLASMA DERIVATIVE
</ProductTypeName>
<ProprietaryName>
Riastap
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fibrinogen Human
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20090116
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125317
</ApplicationNumber>
<LabelerName>
CSL Behring GmbH
</LabelerName>
<SubstanceName>
FIBRINOGEN HUMAN
</SubstanceName>
<StrengthNumber>
2600
</StrengthNumber>
<StrengthUnit>
mg/100mL
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20090116
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>