<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
44567-602-24
</NDCCode>
<PackageDescription>
24 BAG in 1 CARTON (44567-602-24) / 50 mL in 1 BAG
</PackageDescription>
<NDC11Code>
44567-0602-24
</NDC11Code>
<ProductNDC>
44567-602
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dexmedetomidine In Dextrose
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dexmedetomidine
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20160419
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA206628
</ApplicationNumber>
<LabelerName>
WG Critical Care, LLC
</LabelerName>
<SubstanceName>
DEXMEDETOMIDINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
ug/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20181018
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>