<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72526-107-11
</NDCCode>
<PackageDescription>
1 SYRINGE, GLASS in 1 KIT (72526-107-11) / .75 mL in 1 SYRINGE, GLASS
</PackageDescription>
<NDC11Code>
72526-0107-11
</NDC11Code>
<ProductNDC>
72526-107
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Erzofri Extended-release
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Paliperidone Palmitate
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20241210
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216352
</ApplicationNumber>
<LabelerName>
Shandong Luye Pharmaceutical Co., Ltd.
</LabelerName>
<SubstanceName>
PALIPERIDONE PALMITATE
</SubstanceName>
<StrengthNumber>
117
</StrengthNumber>
<StrengthUnit>
mg/.75mL
</StrengthUnit>
<Pharm_Classes>
Atypical Antipsychotic [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241210
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>