69528-310-16 : NDC 2026 Code

69528-310-16 : Tizanidine Hydrochloride ( Ontralfy )

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NDC Code : 69528-310-16 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "69528-310-16",
    "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (69528-310-16) ",
    "NDC11Code": "69528-0310-16",
    "ProductNDC": "69528-310",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Ontralfy",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Tizanidine Hydrochloride",
    "DosageFormName": "SOLUTION",
    "RouteName": "ORAL",
    "StartMarketingDate": "20250331",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA216190",
    "LabelerName": "Rosemont Pharmaceuticals, LLC",
    "SubstanceName": "TIZANIDINE HYDROCHLORIDE",
    "StrengthNumber": "2",
    "StrengthUnit": "mg/5mL",
    "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2026-02-19",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20271231",
    "StartMarketingDatePackage": "20251001",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}