<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72606-043-01
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (72606-043-01) / 10 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
72606-0043-01
</NDC11Code>
<ProductNDC>
72606-043
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Avtozma
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tocilizumab
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250126
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761420
</ApplicationNumber>
<LabelerName>
CELLTRION USA, Inc.
</LabelerName>
<SubstanceName>
TOCILIZUMAB
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes>
Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250126
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>