<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63481-624-10
</NDCCode>
<PackageDescription>
10 AMPULE in 1 CARTON (63481-624-10) > 1 mL in 1 AMPULE (63481-624-01)
</PackageDescription>
<NDC11Code>
63481-0624-10
</NDC11Code>
<ProductNDC>
63481-624
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Opana
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Oxymorphone Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
19590601
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA011707
</ApplicationNumber>
<LabelerName>
Endo Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
OXYMORPHONE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
</Pharm_Classes>
<DEASchedule>
CII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-10-20
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>