<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61755-019-01
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (61755-019-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-019-00)
</PackageDescription>
<NDC11Code>
61755-0019-01
</NDC11Code>
<ProductNDC>
61755-019
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Inmazeb
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Atoltivimab, Maftivimab, And Odesivimab-ebgn
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20210729
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761169
</ApplicationNumber>
<LabelerName>
Regeneron Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB
</SubstanceName>
<StrengthNumber>
483.3; 483.3; 483.3
</StrengthNumber>
<StrengthUnit>
mg/14.5mL; mg/14.5mL; mg/14.5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210729
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>