<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71894-200-02
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (71894-200-02) / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01)
</PackageDescription>
<NDC11Code>
71894-0200-02
</NDC11Code>
<ProductNDC>
71894-200
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Itvisma
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Onasemnogene Abeparvovec-brve
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRATHECAL
</RouteName>
<StartMarketingDate>
20251124
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125856
</ApplicationNumber>
<LabelerName>
Novartis Gene Therapies, Inc.
</LabelerName>
<SubstanceName>
ONASEMNOGENE ABEPARVOVEC
</SubstanceName>
<StrengthNumber>
40000000000000
</StrengthNumber>
<StrengthUnit>
[arb'U]/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251124
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>