{
"NDC": {
"NDCCode": "44523-120-16",
"PackageDescription": "470 mL in 1 BOTTLE (44523-120-16) ",
"NDC11Code": "44523-0120-16",
"ProductNDC": "44523-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Gabapentin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231130",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078974",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231130",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}