<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
14803-902-00
</NDCCode>
<PackageDescription>
14400 CAPSULE in 1 BOX (14803-902-00)
</PackageDescription>
<NDC11Code>
14803-0902-00
</NDC11Code>
<ProductNDC>
14803-902
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen ,dextromethorphan Hydrobromide, Doxylamine Succinate
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20241128
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Elysium Pharmaceuticals Ltd.
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; DEXTROMETHORPHAN; DOXYLAMINE SUCCINATE
</SubstanceName>
<StrengthNumber>
325; 15; 6.25
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-02-16
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
29-NOV-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>