<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61786-218-16
</NDCCode>
<PackageDescription>
50 mL in 1 VIAL, SINGLE-DOSE (61786-218-16)
</PackageDescription>
<NDC11Code>
61786-0218-16
</NDC11Code>
<ProductNDC>
61786-218
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dextrose
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dextrose Monohydrate
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20150310
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA019445
</ApplicationNumber>
<LabelerName>
REMEDYREPACK INC.
</LabelerName>
<SubstanceName>
DEXTROSE MONOHYDRATE
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
g/50mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-08-29
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>