{
"NDC": {
"NDCCode": "54799-920-25",
"PackageDescription": "2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25) ",
"NDC11Code": "54799-0920-25",
"ProductNDC": "54799-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Retaine Allergy",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240705",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209420",
"LabelerName": "OCuSOFT INC.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240705",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}