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    NDC 69848-0018-16 Guaifenesin 1200 mg/1 Details

    Guaifenesin 1200 mg/1

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

    Product Information

    NDC 69848-0018
    Product ID 69848-018_0dfd5775-138b-c205-e063-6394a90a2022
    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 1200
    Active Ingredient Units mg/1
    Substance Name GUAIFENESIN
    Labeler Name GRANULES USA, INC.
    Pharmaceutical Class Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213420
    Listing Certified Through 2025-12-31

    Package

    NDC 69848-0018-16 (69848001816)

    NDC Package Code 69848-018-16
    Billing NDC 69848001816
    Package 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-018-16)
    Marketing Start Date 2021-02-21
    NDC Exclude Flag N
    Pricing Information N/A