<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72507-800-04
</NDCCode>
<PackageDescription>
4 VIAL in 1 CARTON (72507-800-04) / 3.5 mL in 1 VIAL (72507-800-30)
</PackageDescription>
<NDC11Code>
72507-0800-04
</NDC11Code>
<ProductNDC>
72507-800
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Forzinity
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Elamipretide Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20251030
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA215244
</ApplicationNumber>
<LabelerName>
Stealth Biotherapeutics Inc.
</LabelerName>
<SubstanceName>
ELAMIPRETIDE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
280
</StrengthNumber>
<StrengthUnit>
mg/3.5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251030
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>