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    NDC 71205-0474-30 Baclofen 10 mg/1 Details

    Baclofen 10 mg/1

    Baclofen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is BACLOFEN.

    Product Information

    NDC 71205-0474
    Product ID 71205-474_4702c59e-202c-4900-9388-f64788cb035c
    Associated GPIs 75100010000305
    GCN Sequence Number 004679
    GCN Sequence Number Description baclofen TABLET 10 MG ORAL
    HIC3 H6H
    HIC3 Description SKELETAL MUSCLE RELAXANTS
    GCN 18010
    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 TABLET
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name BACLOFEN
    Labeler Name Proficient Rx LP
    Pharmaceutical Class GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078504
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0474-30 (71205047430)

    NDC Package Code 71205-474-30
    Billing NDC 71205047430
    Package 30 TABLET in 1 BOTTLE (71205-474-30)
    Marketing Start Date 2020-08-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL b65d3089-0412-487f-a1b4-66f0bc6f398e Details

    Revised: 3/2022