<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61953-0020-7
</NDCCode>
<PackageDescription>
1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-7) / 10 mL in 1 SYRINGE, GLASS (61953-0020-8)
</PackageDescription>
<NDC11Code>
61953-0020-07
</NDC11Code>
<ProductNDC>
61953-0020
</ProductNDC>
<ProductTypeName>
PLASMA DERIVATIVE
</ProductTypeName>
<ProprietaryName>
Vistaseal
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Human Fibrinogen, Human Thrombin
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20191101
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125640
</ApplicationNumber>
<LabelerName>
GRIFOLS USA, LLC
</LabelerName>
<SubstanceName>
FIBRINOGEN HUMAN; HUMAN THROMBIN
</SubstanceName>
<StrengthNumber>
80; 500
</StrengthNumber>
<StrengthUnit>
mg/mL; [iU]/mL
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-12-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20191101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>