{
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"PackageDescription": "25 CARTON in 1 CASE (0409-1464-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1464-61) / 10 mL in 1 VIAL, MULTI-DOSE",
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"ProprietaryName": "Nalbuphine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nalbuphine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
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"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070915",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NALBUPHINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050719",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}