<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80674-210-10
</NDCCode>
<PackageDescription>
10 VIAL, SINGLE-USE in 1 CARTON (80674-210-10) / 10 mL in 1 VIAL, SINGLE-USE (80674-210-01)
</PackageDescription>
<NDC11Code>
80674-0210-10
</NDC11Code>
<ProductNDC>
80674-210
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sesquient
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fosphenytoin Sodium
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20210601
</StartMarketingDate>
<EndMarketingDate>
20231231
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA210864
</ApplicationNumber>
<LabelerName>
Sedor Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
FOSPHENYTOIN SODIUM
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes>
Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2024-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20210601
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20231231
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>