<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
12854-659-01
</NDCCode>
<PackageDescription>
6 TRAY in 1 BOX (12854-659-01) / 25 VIAL, SINGLE-DOSE in 1 TRAY / 10.77 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
12854-0659-01
</NDC11Code>
<ProductNDC>
12854-659
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Isatuximab
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION, CONCENTRATE
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20260423
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Sanofi-Aventis Deutschland GmbH
</LabelerName>
<SubstanceName>
ISATUXIMAB
</SubstanceName>
<StrengthNumber>
1400
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2014-02-04
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
23-APR-26
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>