<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
62332-417-91
</NDCCode>
<PackageDescription>
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-417-91)
</PackageDescription>
<NDC11Code>
62332-0417-91
</NDC11Code>
<ProductNDC>
62332-417
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lamotrigine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lamotrigine
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20241007
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA211821
</ApplicationNumber>
<LabelerName>
Alembic Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
LAMOTRIGINE
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-10-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241007
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>