<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68982-349-02
</NDCCode>
<PackageDescription>
1 BOTTLE, GLASS in 1 CARTON (68982-349-02) / 100 mL in 1 BOTTLE, GLASS (68982-349-82)
</PackageDescription>
<NDC11Code>
68982-0349-02
</NDC11Code>
<ProductNDC>
68982-349
</ProductNDC>
<ProductTypeName>
PLASMA DERIVATIVE
</ProductTypeName>
<ProprietaryName>
Fibryga
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fibrinogen (human)
</NonProprietaryName>
<DosageFormName>
POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20241220
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125612
</ApplicationNumber>
<LabelerName>
Octapharma USA Inc
</LabelerName>
<SubstanceName>
FIBRINOGEN HUMAN
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-08-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241220
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>