{
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"PackageDescription": "100 TABLET in 1 BOTTLE (53746-116-01) ",
"NDC11Code": "53746-0116-01",
"ProductNDC": "53746-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Hydrocodone Bitartrate And Ibuprofen",
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"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076642",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; IBUPROFEN",
"StrengthNumber": "2.5; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
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"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100218",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}