<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55154-5117-8
</NDCCode>
<PackageDescription>
1 VIAL in 1 BAG (55154-5117-8) > 2 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
55154-5117-08
</NDC11Code>
<ProductNDC>
55154-5117
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Phenytoin Sodium
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Phenytoin Sodium
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
19750716
</StartMarketingDate>
<EndMarketingDate>
20191031
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA084307
</ApplicationNumber>
<LabelerName>
Cardinal Health
</LabelerName>
<SubstanceName>
PHENYTOIN SODIUM
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-11-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
19750716
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20191031
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>