{
"NDC": {
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"PackageDescription": "1 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLE",
"NDC11Code": "61314-0126-10",
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"ProprietaryNameSuffix": null,
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
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"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076583",
"LabelerName": "Sandoz Inc",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091105",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}