<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
23155-895-06
</NDCCode>
<PackageDescription>
60 CAPSULE in 1 BOTTLE (23155-895-06)
</PackageDescription>
<NDC11Code>
23155-0895-06
</NDC11Code>
<ProductNDC>
23155-895
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Topiramate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Topiramate Spinkle
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240216
</StartMarketingDate>
<EndMarketingDate>
20260228
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA078418
</ApplicationNumber>
<LabelerName>
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
TOPIRAMATE
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20240216
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260228
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>