<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68788-8152-1
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (68788-8152-1) / 10 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
68788-8152-01
</NDC11Code>
<ProductNDC>
68788-8152
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Polymyxin B Sulfate And Trimethoprim
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Polymyxin B Sulfate And Trimethoprim Sulfate
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20220314
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA064120
</ApplicationNumber>
<LabelerName>
Preferred Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
</SubstanceName>
<StrengthNumber>
10000; 1
</StrengthNumber>
<StrengthUnit>
[USP'U]/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220314
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>