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    NDC 52817-0620-08 Baclofen 10 mg/5mL Details

    Baclofen 10 mg/5mL

    Baclofen is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TRUPHARMA, LLC. The primary component is BACLOFEN.

    Product Information

    NDC 52817-0620
    Product ID 52817-620_0806a6f9-b626-f98e-e063-6294a90a84bb
    Associated GPIs
    GCN Sequence Number 085432
    GCN Sequence Number Description baclofen SOLUTION 10 MG/5 ML ORAL
    HIC3 H6H
    HIC3 Description SKELETAL MUSCLE RELAXANTS
    GCN 54913
    HICL Sequence Number 001949
    HICL Sequence Number Description BACLOFEN
    Brand/Generic Generic
    Proprietary Name Baclofen
    Proprietary Name Suffix n/a
    Non-Proprietary Name Baclofen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/5mL
    Substance Name BACLOFEN
    Labeler Name TRUPHARMA, LLC
    Pharmaceutical Class GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category NDA AUTHORIZED GENERIC
    Application Number NDA208193
    Listing Certified Through 2024-12-31

    Package

    NDC 52817-0620-08 (52817062008)

    NDC Package Code 52817-620-08
    Billing NDC 52817062008
    Package 237 mL in 1 BOTTLE (52817-620-08)
    Marketing Start Date 2023-10-12
    NDC Exclude Flag N
    Pricing Information N/A