{
"NDC": {
"NDCCode": "63304-650-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (63304-650-60) ",
"NDC11Code": "63304-0650-60",
"ProductNDC": "63304-650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextromethorphan Hydrobromide And Quinidine Sulphate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dextromethorphan Hydrobromide And Quinidine Sulphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260730",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204196",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260730",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}