<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68071-1739-5
</NDCCode>
<PackageDescription>
15 mL in 1 BOTTLE (68071-1739-5)
</PackageDescription>
<NDC11Code>
68071-1739-05
</NDC11Code>
<ProductNDC>
68071-1739
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Acetic Acid
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetic Acid
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20100122
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA012179
</ApplicationNumber>
<LabelerName>
NuCare Pharmaceuticals,Inc.
</LabelerName>
<SubstanceName>
ACETIC ACID
</SubstanceName>
<StrengthNumber>
20.65
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20180827
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>