{
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"PackageDescription": "1 BOTTLE in 1 CARTON (70954-801-20) / 200 mL in 1 BOTTLE",
"NDC11Code": "70954-0801-20",
"ProductNDC": "70954-801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260713",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219119",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260713",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}