<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
69315-248-48
</NDCCode>
<PackageDescription>
473 mL in 1 BOTTLE (69315-248-48)
</PackageDescription>
<NDC11Code>
69315-0248-48
</NDC11Code>
<ProductNDC>
69315-248
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Codeine Guaifenesin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Codeine Phosphate, Guaifenesin
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20191219
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH FINAL
</MarketingCategoryName>
<ApplicationNumber>
part341
</ApplicationNumber>
<LabelerName>
Leading Pharma, LLC
</LabelerName>
<SubstanceName>
CODEINE PHOSPHATE; GUAIFENESIN
</SubstanceName>
<StrengthNumber>
10; 100
</StrengthNumber>
<StrengthUnit>
mg/5mL; mg/5mL
</StrengthUnit>
<Pharm_Classes>
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
</Pharm_Classes>
<DEASchedule>
CV
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2022-08-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20221231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20191219
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>