<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51079-727-20
</NDCCode>
<PackageDescription>
100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-727-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-727-01)
</PackageDescription>
<NDC11Code>
51079-0727-20
</NDC11Code>
<ProductNDC>
51079-727
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Topiramate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Topiramate
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20090420
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA076314
</ApplicationNumber>
<LabelerName>
Mylan institutional Inc.
</LabelerName>
<SubstanceName>
TOPIRAMATE
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-05-23
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>