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    NDC 00406-1170-03 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 SpecGx LLC. The primary component is NALTREXONE HYDROCHLORIDE.

    Product Information

    NDC 00406-1170
    Product ID 0406-1170_e584f90b-2dab-450b-8968-f736af25e412
    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 SpecGx LLC
    Pharmaceutical Class Opioid Antagonist [EPC], Opioid Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076264
    Listing Certified Through 2024-12-31

    Package

    NDC 00406-1170-03 (00406117003)

    NDC Package Code 0406-1170-03
    Billing NDC 00406117003
    Package 30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03)
    Marketing Start Date 2002-03-22
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.67743
    Pricing Unit EA
    Effective Date 2022-11-23
    NDC Description NALTREXONE 50 MG TABLET
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 06ff2d5a-e62b-4fa4-bbdb-01938535bc65 Details

    Revised: 9/2022