<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55390-130-40
</NDCCode>
<PackageDescription>
1 VIAL in 1 BOX, UNIT-DOSE (55390-130-40) > 40 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
55390-0130-40
</NDC11Code>
<ProductNDC>
55390-130
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Labetalol Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Labetalol Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
19991129
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075303
</ApplicationNumber>
<LabelerName>
Bedford Laboratories
</LabelerName>
<SubstanceName>
LABETALOL HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2014-02-19
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>