<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63323-403-09
</NDCCode>
<PackageDescription>
25 VIAL in 1 TRAY (63323-403-09) > 2 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
63323-0403-09
</NDC11Code>
<ProductNDC>
63323-403
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Fosphenytoin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fosphenytoin Sodium
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
20091214
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA078052
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
FOSPHENYTOIN 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>
2017-10-23
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>