{
"NDC": {
"NDCCode": "72485-617-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "72485-0617-10",
"ProductNDC": "72485-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ketotifen Fumarate Ophthalmic Solution",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20231009",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077958",
"LabelerName": "Armas Pharmaceuticals Inc.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2024-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231009",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}