<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
69497-0002-0
</NDCCode>
<PackageDescription>
63 VIAL, SINGLE-DOSE in 1 TRAY (69497-0002-0) > 40 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
69497-0002-00
</NDC11Code>
<ProductNDC>
69497-0002
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bezlotoxumab
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20161023
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
MSD Ireland (Carlow)
</LabelerName>
<SubstanceName>
BEZLOTOXUMAB
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2018-02-15
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>