{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (51013-666-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "51013-0666-01",
"ProductNDC": "51013-666",
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"ProprietaryNameSuffix": null,
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20250312",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "PuraCap Pharmaceutical LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "325; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "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",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250312",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}