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    NDC 58602-0810-12 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 Aurohealth LLC. The primary component is GUAIFENESIN.

    Product Information

    NDC 58602-0810
    Product ID 58602-810_7fc201de-1528-481d-8aa1-167de18cc828
    Associated GPIs
    GCN Sequence Number 071885
    GCN Sequence Number Description guaifenesin TAB ER 12H 600 MG ORAL
    HIC3 B3J
    HIC3 Description EXPECTORANTS
    GCN 35905
    HICL Sequence Number 000271
    HICL Sequence Number Description GUAIFENESIN
    Brand/Generic Generic
    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 Aurohealth LLC
    Pharmaceutical Class Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210453
    Listing Certified Through 2024-12-31

    Package

    NDC 58602-0810-12 (58602081012)

    NDC Package Code 58602-810-12
    Billing NDC 58602081012
    Package 1 BOTTLE in 1 CARTON (58602-810-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
    Marketing Start Date 2019-10-21
    NDC Exclude Flag N
    Pricing Information N/A