68475-513-01 : NDC 2026 Code

68475-513-01 : Sodium Phenylacetate And Sodium Benzoate ( Sodium Phenylacetate And Sodium Benzoate )

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NDC Code : 68475-513-01 – JSON Data Format

                
{
  "NDC": {
    "NDCCode": "68475-513-01",
    "PackageDescription": "1 VIAL in 1 CARTON (68475-513-01)  / 20 mL in 1 VIAL",
    "NDC11Code": "68475-0513-01",
    "ProductNDC": "68475-513",
    "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
    "ProprietaryName": "Sodium Phenylacetate And Sodium Benzoate",
    "ProprietaryNameSuffix": null,
    "NonProprietaryName": "Sodium Phenylacetate And Sodium Benzoate",
    "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
    "RouteName": "INTRAVENOUS",
    "StartMarketingDate": "20251206",
    "EndMarketingDate": null,
    "MarketingCategoryName": "ANDA",
    "ApplicationNumber": "ANDA217526",
    "LabelerName": "Navinta LLC",
    "SubstanceName": "SODIUM BENZOATE; SODIUM PHENYLACETATE",
    "StrengthNumber": "100; 100",
    "StrengthUnit": "mg/mL; mg/mL",
    "Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]",
    "DEASchedule": null,
    "Status": "Active",
    "LastUpdate": "2025-12-16",
    "PackageNdcExcludeFlag": "N",
    "ProductNdcExcludeFlag": "N",
    "ListingRecordCertifiedThrough": "20261231",
    "StartMarketingDatePackage": "20251206",
    "EndMarketingDatePackage": null,
    "SamplePackage": "N"
  }
}