<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70121-2626-5
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1)
</PackageDescription>
<NDC11Code>
70121-2626-05
</NDC11Code>
<ProductNDC>
70121-2626
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Risperidone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Risperidone
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20250908
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218586
</ApplicationNumber>
<LabelerName>
Amneal Pharmaceuticals LLC
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250908
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>