<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72874-001-01
</NDCCode>
<PackageDescription>
50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)
</PackageDescription>
<NDC11Code>
72874-0001-01
</NDC11Code>
<ProductNDC>
72874-001
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cerianna
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fluoroestradiol F 18
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20200520
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA212155
</ApplicationNumber>
<LabelerName>
GE Healthcare Inc.
</LabelerName>
<SubstanceName>
FLUOROESTRADIOL F-18
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mCi/mL
</StrengthUnit>
<Pharm_Classes>
Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200520
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>