<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0024-0674-01
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (0024-0674-01) / 10 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
00024-0674-01
</NDC11Code>
<ProductNDC>
0024-0674
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sarclisa Escena
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Isatuximab-irfc
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20260709
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761445
</ApplicationNumber>
<LabelerName>
Sanofi-Aventis U.S. LLC
</LabelerName>
<SubstanceName>
ISATUXIMAB
</SubstanceName>
<StrengthNumber>
140
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260709
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>