<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
16571-820-41
</NDCCode>
<PackageDescription>
14 CAPSULE in 1 BOTTLE (16571-820-41)
</PackageDescription>
<NDC11Code>
16571-0820-41
</NDC11Code>
<ProductNDC>
16571-820
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Temozolomide
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Temozolomide
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20221004
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA206309
</ApplicationNumber>
<LabelerName>
Rising Pharma Holdings, Inc.
</LabelerName>
<SubstanceName>
TEMOZOLOMIDE
</SubstanceName>
<StrengthNumber>
180
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Alkylating Activity [MoA], Alkylating Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20221004
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>