<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
24338-707-04
</NDCCode>
<PackageDescription>
2 BLISTER PACK in 1 CARTON (24338-707-04) > 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-707-02)
</PackageDescription>
<NDC11Code>
24338-0707-04
</NDC11Code>
<ProductNDC>
24338-707
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cetylev
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetylcysteine
</NonProprietaryName>
<DosageFormName>
TABLET, EFFERVESCENT
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20170213
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA207916
</ApplicationNumber>
<LabelerName>
Arbor Pharmaceuticals
</LabelerName>
<SubstanceName>
ACETYLCYSTEINE
</SubstanceName>
<StrengthNumber>
2.5
</StrengthNumber>
<StrengthUnit>
g/1
</StrengthUnit>
<Pharm_Classes>
Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-04-03
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>