<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52125-249-01
</NDCCode>
<PackageDescription>
50 mL in 1 VIAL, MULTI-DOSE (52125-249-01)
</PackageDescription>
<NDC11Code>
52125-0249-01
</NDC11Code>
<ProductNDC>
52125-249
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Marcaine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bupivacaine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INFILTRATION
</RouteName>
<StartMarketingDate>
20130612
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA016694
</ApplicationNumber>
<LabelerName>
REMEDYREPACK INC.
</LabelerName>
<SubstanceName>
BUPIVACAINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-01-24
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>