Search by Drug Name or NDC

    NDC 72888-0009-05 BACLOFEN 5 mg/1 Details

    BACLOFEN 5 mg/1

    BACLOFEN is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Advagen Pharma Limited. The primary component is BACLOFEN.

    Product Information

    NDC 72888-0009
    Product ID 72888-009_ffa4e3dc-9e52-dc9d-e053-6294a90a59b3
    Associated GPIs 75100010000303
    GCN Sequence Number 027229
    GCN Sequence Number Description baclofen TABLET 5 MG ORAL
    HIC3 H6H
    HIC3 Description SKELETAL MUSCLE RELAXANTS
    GCN 18012
    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 5
    Active Ingredient Units mg/1
    Substance Name BACLOFEN
    Labeler Name Advagen Pharma Limited
    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 ANDA209102
    Listing Certified Through 2024-12-31

    Package

    NDC 72888-0009-05 (72888000905)

    NDC Package Code 72888-009-05
    Billing NDC 72888000905
    Package 500 TABLET in 1 BOTTLE (72888-009-05)
    Marketing Start Date 2018-04-01
    NDC Exclude Flag N
    Pricing Information N/A