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    NDC 42291-0632-30 Naltrexone Hydrochloride 50 mg/1 Details

    Naltrexone Hydrochloride 50 mg/1

    Naltrexone Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is NALTREXONE HYDROCHLORIDE.

    Product Information

    NDC 42291-0632
    Product ID 42291-632_0e9921e5-8ee7-5fe0-e063-6294a90a8765
    Associated GPIs 93400030100305
    GCN Sequence Number 004518
    GCN Sequence Number Description naltrexone HCl TABLET 50 MG ORAL
    HIC3 H3T
    HIC3 Description OPIOID ANTAGONISTS
    GCN 17070
    HICL Sequence Number 001875
    HICL Sequence Number Description NALTREXONE HCL
    Brand/Generic Generic
    Proprietary Name Naltrexone Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Naltrexone Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name NALTREXONE HYDROCHLORIDE
    Labeler Name AvKARE
    Pharmaceutical Class Opioid Antagonist [EPC], Opioid Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075274
    Listing Certified Through 2025-12-31

    Package

    NDC 42291-0632-30 (42291063230)

    NDC Package Code 42291-632-30
    Billing NDC 42291063230
    Package 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)
    Marketing Start Date 2015-03-26
    NDC Exclude Flag N
    Pricing Information N/A