<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87754-0002-1
</NDCCode>
<PackageDescription>
60 U in 1 BOTTLE (87754-0002-1)
</PackageDescription>
<NDC11Code>
87754-0002-01
</NDC11Code>
<ProductNDC>
87754-0002
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Spirudio
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Spirudio
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
SUBLINGUAL
</RouteName>
<StartMarketingDate>
20260601
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
PROGRESYVUS TYRIMAI MB
</LabelerName>
<SubstanceName>
LAPINE S-100 IMMUNE GLOBULIN
</SubstanceName>
<StrengthNumber>
30
</StrengthNumber>
<StrengthUnit>
[hp_C]/U
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260601
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>