{
"NDC": {
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"PackageDescription": "10 AMPULE in 1 CARTON (70069-672-10) / 1 mL in 1 AMPULE (70069-672-01) ",
"NDC11Code": "70069-0672-10",
"ProductNDC": "70069-672",
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"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nalbuphine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20240925",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216050",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "NALBUPHINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": null,
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"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240925",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}