<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52584-901-25
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 BAG (52584-901-25) > 1 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
52584-0901-25
</NDC11Code>
<ProductNDC>
52584-901
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hydralazine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hydralazine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
20100801
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA040136
</ApplicationNumber>
<LabelerName>
General Injectables & Vaccines, Inc
</LabelerName>
<SubstanceName>
HYDRALAZINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-01-18
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>