<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61703-347-35
</NDCCode>
<PackageDescription>
25 mL in 1 VIAL, SINGLE-USE (61703-347-35)
</PackageDescription>
<NDC11Code>
61703-0347-35
</NDC11Code>
<ProductNDC>
61703-347
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Epirubicin Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Epirubicin Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20060915
</StartMarketingDate>
<EndMarketingDate>
20140831
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA050807
</ApplicationNumber>
<LabelerName>
Hospira Worldwide, Inc.
</LabelerName>
<SubstanceName>
EPIRUBICIN HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/25mL
</StrengthUnit>
<Pharm_Classes>
Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2014-09-05
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>