{
"NDC": {
"NDCCode": "68071-1651-5",
"PackageDescription": "10 mL in 1 BOX (68071-1651-5) ",
"NDC11Code": "68071-1651-05",
"ProductNDC": "68071-1651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polymyxin B Sulfate And Trimethoprim",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Polymyxin B Sulfate And Trimethoprim Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19970214",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064120",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
"StrengthNumber": "10000; 1",
"StrengthUnit": "[USP'U]/mL; mg/mL",
"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]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170803",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}