<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52856-601-01
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11)
</PackageDescription>
<NDC11Code>
52856-0601-01
</NDC11Code>
<ProductNDC>
52856-601
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Kebilidi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Eladocagene Exuparvovec-tneq
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
INTRACEREBRAL
</RouteName>
<StartMarketingDate>
20241113
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125722
</ApplicationNumber>
<LabelerName>
PTC Therapeutics, Inc.
</LabelerName>
<SubstanceName>
ELADOCAGENE EXUPARVOVEC
</SubstanceName>
<StrengthNumber>
560000000000
</StrengthNumber>
<StrengthUnit>
{GC}/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241113
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>