<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65857-901-10
</NDCCode>
<PackageDescription>
1 VIAL, MULTI-DOSE in 1 CONTAINER (65857-901-10) > 10 mL in 1 VIAL, MULTI-DOSE
</PackageDescription>
<NDC11Code>
65857-0901-10
</NDC11Code>
<ProductNDC>
65857-901
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Flutemetamol F-18
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Flutemetamol F-18
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20140301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
</MarketingCategoryName>
<ApplicationNumber>
NDA203137
</ApplicationNumber>
<LabelerName>
Cardinal Health 414, LLC
</LabelerName>
<SubstanceName>
FLUTEMETAMOL F-18
</SubstanceName>
<StrengthNumber>
4.05
</StrengthNumber>
<StrengthUnit>
uCi/mL
</StrengthUnit>
<Pharm_Classes>
Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-12-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20181231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>