<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82613-002-01
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BAG (82613-002-01) / 150 g in 1 BOTTLE
</PackageDescription>
<NDC11Code>
82613-0002-01
</NDC11Code>
<ProductNDC>
82613-002
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fitusiran
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20250328
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
BioSpring Gesellschaft f�r Biotechnologie mbH
</LabelerName>
<SubstanceName>
FITUSIRAN
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
g/g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-02-26
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
28-MAR-25
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>