<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42291-698-50
</NDCCode>
<PackageDescription>
500 TABLET, FILM COATED in 1 BOTTLE (42291-698-50)
</PackageDescription>
<NDC11Code>
42291-0698-50
</NDC11Code>
<ProductNDC>
42291-698
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Quetiapine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Quetiapine
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20220525
</StartMarketingDate>
<EndMarketingDate>
20260331
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA077745
</ApplicationNumber>
<LabelerName>
AvKARE
</LabelerName>
<SubstanceName>
QUETIAPINE FUMARATE
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Atypical Antipsychotic [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20220525
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260331
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>