<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
14803-306-00
</NDCCode>
<PackageDescription>
25000 TABLET in 1 BOX (14803-306-00)
</PackageDescription>
<NDC11Code>
14803-0306-00
</NDC11Code>
<ProductNDC>
14803-306
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Guaifenesin And Dextromethorphan Hbr
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240207
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Elysium Pharmaceuticals Ltd.
</LabelerName>
<SubstanceName>
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
</SubstanceName>
<StrengthNumber>
20; 400
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-07-20
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
07-MAR-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>