<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70518-4498-0
</NDCCode>
<PackageDescription>
20 TABLET in 1 BOTTLE, PLASTIC (70518-4498-0)
</PackageDescription>
<NDC11Code>
70518-4498-00
</NDC11Code>
<ProductNDC>
70518-4498
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Prochlorperazine Maleate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Prochlorperazine Maleate
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251011
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217478
</ApplicationNumber>
<LabelerName>
REMEDYREPACK INC.
</LabelerName>
<SubstanceName>
PROCHLORPERAZINE MALEATE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Phenothiazine [EPC], Phenothiazines [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251011
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>