<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0054-0975-80
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (0054-0975-80) / 10 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
00054-0975-80
</NDC11Code>
<ProductNDC>
0054-0975
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Neomycin And Polymyxin B Sulfates And Hydrocortisone
</ProprietaryName>
<ProprietaryNameSuffix>
Otic
</ProprietaryNameSuffix>
<NonProprietaryName>
Neomycin And Polymyxin B Sulfates And Hydrocortisone
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20261008
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220938
</ApplicationNumber>
<LabelerName>
Hikma Pharmaceuticals USA Inc.
</LabelerName>
<SubstanceName>
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
</SubstanceName>
<StrengthNumber>
3.5; 10000; 10
</StrengthNumber>
<StrengthUnit>
mg/mL; [iU]/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-10-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261008
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>