{
"NDC": {
"NDCCode": "68001-674-92",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (68001-674-92) / 2.5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "68001-0674-92",
"ProductNDC": "68001-674",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20250915",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219557",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"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": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250915",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}