<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0469-6501-89
</NDCCode>
<PackageDescription>
5 mL in 1 SYRINGE, PLASTIC (0469-6501-89)
</PackageDescription>
<NDC11Code>
00469-6501-89
</NDC11Code>
<ProductNDC>
0469-6501
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lexiscan
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Regadenoson
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20080410
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA022161
</ApplicationNumber>
<LabelerName>
Astellas Pharma US, Inc.
</LabelerName>
<SubstanceName>
REGADENOSON
</SubstanceName>
<StrengthNumber>
.08
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2019-02-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20080410
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>