<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87069-129-63
</NDCCode>
<PackageDescription>
18 POUCH in 1 CARTON (87069-129-63) / 3 BAG in 1 POUCH / 70 mL in 1 BAG
</PackageDescription>
<NDC11Code>
87069-0129-63
</NDC11Code>
<ProductNDC>
87069-129
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Leukotrap Rc System
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cp2d/as-3 Triple Blood Bag Unit With In-line Rc2d Filter And Sampling System
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260302
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
BN820915
</ApplicationNumber>
<LabelerName>
GVS TM INC
</LabelerName>
<SubstanceName>
DEXTROSE, UNSPECIFIED FORM
</SubstanceName>
<StrengthNumber>
3.57
</StrengthNumber>
<StrengthUnit>
g/70mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260302
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>