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    NDC 65162-0036-06 Guaifenesin 600 mg/1 Details

    Guaifenesin 600 mg/1

    Guaifenesin is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is GUAIFENESIN.

    Product Information

    NDC 65162-0036
    Product ID 65162-036_b58f3f20-7c61-4825-bd4a-99f142fde719
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Guaifenesin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Guaifenesin
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 600
    Active Ingredient Units mg/1
    Substance Name GUAIFENESIN
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207342
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0036-06 (65162003606)

    NDC Package Code 65162-036-06
    Billing NDC 65162003606
    Package 1 BOTTLE in 1 CARTON (65162-036-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
    Marketing Start Date 2018-07-27
    NDC Exclude Flag N
    Pricing Information N/A