<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68788-9702-5
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (68788-9702-5) / 5 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
68788-9702-05
</NDC11Code>
<ProductNDC>
68788-9702
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Neomycin Polymyxin B Sulfates And Dexamethasone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
</NonProprietaryName>
<DosageFormName>
SUSPENSION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20130314
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA064135
</ApplicationNumber>
<LabelerName>
Preferred Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
</SubstanceName>
<StrengthNumber>
1; 3.5; 10000
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL; [USP'U]/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>
2025-08-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20130314
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>