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    NDC 00409-1463-49 Nalbuphine Hydrochloride 10 mg/mL Details

    Nalbuphine Hydrochloride 10 mg/mL

    Nalbuphine Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is NALBUPHINE HYDROCHLORIDE.

    Product Information

    NDC 00409-1463
    Product ID 0409-1463_c6be438f-eb10-48bd-bcdb-2b58569850b8
    Associated GPIs 65200030102005
    GCN Sequence Number 004229
    GCN Sequence Number Description nalbuphine HCl AMPUL 10 MG/ML INJECTION
    HIC3 H3A
    HIC3 Description OPIOID ANALGESICS
    GCN 16360
    HICL Sequence Number 001744
    HICL Sequence Number Description NALBUPHINE HCL
    Brand/Generic Generic
    Proprietary Name Nalbuphine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name NALBUPHINE HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
    Active Ingredient Strength 10
    Active Ingredient Units mg/mL
    Substance Name NALBUPHINE HYDROCHLORIDE
    Labeler Name Hospira, Inc.
    Pharmaceutical Class Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA070914
    Listing Certified Through 2024-12-31

    Package

    NDC 00409-1463-49 (00409146349)

    NDC Package Code 0409-1463-49
    Billing NDC 00409146349
    Package 10 AMPULE in 1 TRAY (0409-1463-49) / 1 mL in 1 AMPULE (0409-1463-69)
    Marketing Start Date 2008-06-27
    NDC Exclude Flag N
    Pricing Information N/A