{
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"PackageDescription": "10 PACKAGE in 1 CARTON (54288-124-10) / 2 mL in 1 PACKAGE",
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"ProductNDC": "54288-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Naloxone Hydrochloride",
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"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
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"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216977",
"LabelerName": "BPI Labs LLC",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231115",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}