<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64950-353-52
</NDCCode>
<PackageDescription>
50 POUCH in 1 CASE (64950-353-52) / 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-92) / 1 mL in 1 SYRINGE, PLASTIC (64950-353-02)
</PackageDescription>
<NDC11Code>
64950-0353-52
</NDC11Code>
<ProductNDC>
64950-353
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Oxycodone Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Oxycodone Hydrochloride
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20101020
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA200535
</ApplicationNumber>
<LabelerName>
Genus Lifesciences Inc.
</LabelerName>
<SubstanceName>
OXYCODONE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
</Pharm_Classes>
<DEASchedule>
CII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-11-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20201201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>