<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68071-4577-1
</NDCCode>
<PackageDescription>
10 mL in 1 BOTTLE (68071-4577-1)
</PackageDescription>
<NDC11Code>
68071-4577-01
</NDC11Code>
<ProductNDC>
68071-4577
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Neomycin And Polymyxin B Sulfates And Hydrocortisone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20030317
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA062488
</ApplicationNumber>
<LabelerName>
NuCare Pharmaceuticals,Inc.
</LabelerName>
<SubstanceName>
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
</SubstanceName>
<StrengthNumber>
3.5; 10000; 10
</StrengthNumber>
<StrengthUnit>
mg/mL; [USP'U]/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2020-06-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20201231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20180927
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>