0054-0938-21 : NDC 2026 Code

0054-0938-21 : Tapentadol Hydrochloride ( Tapentadol )

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NDC Code : 0054-0938-21 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "0054-0938-21",
    "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0938-21) ",
    "NDC11Code": "00054-0938-21",
    "ProductNDC": "0054-0938",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Tapentadol",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Tapentadol Hydrochloride",
    "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
    "RouteName": "ORAL",
    "StartMarketingDate": "20251215",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
    "ApplicationNumber": "NDA200533",
    "LabelerName": "Hikma Pharmaceuticals USA Inc.",
    "SubstanceName": "TAPENTADOL HYDROCHLORIDE",
    "StrengthNumber": "150",
    "StrengthUnit": "mg/1",
    "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
    "DEASchedule": "CII",
    "Status": "Active",
    "LastUpdate": "2026-03-04",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20271231",
    "StartMarketingDatePackage": "20251215",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}