<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55154-5730-5
</NDCCode>
<PackageDescription>
5 VIAL, GLASS in 1 BAG (55154-5730-5) / 4 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
55154-5730-05
</NDC11Code>
<ProductNDC>
55154-5730
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Acetylcysteine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetylcysteine
</NonProprietaryName>
<DosageFormName>
INHALANT
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20110506
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA072489
</ApplicationNumber>
<LabelerName>
Cardinal Health 107, LLC
</LabelerName>
<SubstanceName>
ACETYLCYSTEINE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/mL
</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>
Active
</Status>
<LastUpdate>
2025-11-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20110506
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>