<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58394-789-99
</NDCCode>
<PackageDescription>
101 kg in 1 BOTTLE (58394-789-99)
</PackageDescription>
<NDC11Code>
58394-0789-99
</NDC11Code>
<ProductNDC>
58394-789
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Coagulation Factor Ix Recombinant Human
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName/>
<StartMarketingDate>
19970201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
</LabelerName>
<SubstanceName>
COAGULATION FACTOR IX RECOMBINANT HUMAN
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
kg/kg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-10-19
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-FEB-97
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>