<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81759-001-30
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CONTAINER (81759-001-30) / 30 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
81759-0001-30
</NDC11Code>
<ProductNDC>
81759-001
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Fludeoxyglucose
</ProprietaryName>
<ProprietaryNameSuffix>
F 18
</ProprietaryNameSuffix>
<NonProprietaryName>
Fludeoxyglucose F-18
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250311
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216125
</ApplicationNumber>
<LabelerName>
BAMF Health Inc.
</LabelerName>
<SubstanceName>
FLUDEOXYGLUCOSE F-18
</SubstanceName>
<StrengthNumber>
400
</StrengthNumber>
<StrengthUnit>
mCi/mL
</StrengthUnit>
<Pharm_Classes>
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-05-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250311
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>