<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63323-151-25
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (63323-151-25) > 25 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
63323-0151-25
</NDC11Code>
<ProductNDC>
63323-151
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Epirubicin Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Epirubicin Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20170731
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA065411
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
EPIRUBICIN HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
2
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2018-12-28
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>