<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
35356-820-30
</NDCCode>
<PackageDescription>
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-820-30)
</PackageDescription>
<NDC11Code>
35356-0820-30
</NDC11Code>
<ProductNDC>
35356-820
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Opana
</ProprietaryName>
<ProprietaryNameSuffix>
Er
</ProprietaryNameSuffix>
<NonProprietaryName>
Oxymorphone Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20120320
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA201655
</ApplicationNumber>
<LabelerName>
Lake Erie Medical DBA Quality Care Products LLC
</LabelerName>
<SubstanceName>
OXYMORPHONE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
</Pharm_Classes>
<DEASchedule>
CII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-11-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20120320
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>