83034-003-65 : NDC 2026 Code

83034-003-65 : Ensifentrine ( Ohtuvayre )

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NDC Code : 83034-003-65 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "83034-003-65",
    "PackageDescription": "60 POUCH in 1 CARTON (83034-003-65)  / 5 AMPULE in 1 POUCH (83034-003-05)  / 2.5 mL in 1 AMPULE",
    "NDC11Code": "83034-0003-65",
    "ProductNDC": "83034-003",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Ohtuvayre",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Ensifentrine",
    "DosageFormName": "SUSPENSION",
    "RouteName": "RESPIRATORY (INHALATION)",
    "StartMarketingDate": "20240626",
    "EndMarketingDate": null,
    "MarketingCategoryName": "NDA",
    "ApplicationNumber": "NDA217389",
    "LabelerName": "Verona Pharma, Inc.",
    "SubstanceName": "ENSIFENTRINE",
    "StrengthNumber": "3",
    "StrengthUnit": "mg/2.5mL",
    "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA], Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2025-08-05",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20240626",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}