<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52584-783-01
</NDCCode>
<PackageDescription>
1 VIAL, MULTI-DOSE in 1 BAG (52584-783-01) > 5 mL in 1 VIAL, MULTI-DOSE
</PackageDescription>
<NDC11Code>
52584-0783-01
</NDC11Code>
<ProductNDC>
52584-783
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Flumazenil
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Flumazenil
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20140916
</StartMarketingDate>
<EndMarketingDate>
20211101
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA078527
</ApplicationNumber>
<LabelerName>
General Injectables and Vaccines, Inc.
</LabelerName>
<SubstanceName>
FLUMAZENIL
</SubstanceName>
<StrengthNumber>
.1
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Benzodiazepine Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2021-11-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20140916
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20211101
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>