<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82958-501-01
</NDCCode>
<PackageDescription>
1 CAPSULE in 1 CONTAINER (82958-501-01) / 1 IMPLANT in 1 CAPSULE
</PackageDescription>
<NDC11Code>
82958-0501-01
</NDC11Code>
<ProductNDC>
82958-501
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Encelto
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Revakinagene Taroretcel-lwey
</NonProprietaryName>
<DosageFormName>
IMPLANT
</DosageFormName>
<RouteName>
INTRAVITREAL
</RouteName>
<StartMarketingDate>
20250312
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125798
</ApplicationNumber>
<LabelerName>
Neurotech Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
REVAKINAGENE TARORETCEL
</SubstanceName>
<StrengthNumber>
440000
</StrengthNumber>
<StrengthUnit>
[arb'U]/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250312
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>