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    NDC 68788-7668-04 MONTELUKAST SODIUM 4 mg/1 Details

    MONTELUKAST SODIUM 4 mg/1

    MONTELUKAST SODIUM is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is MONTELUKAST SODIUM.

    Product Information

    NDC 68788-7668
    Product ID 68788-7668_ca32044e-64dd-48aa-88b3-12a65b766f13
    Associated GPIs 44505050100516
    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 MONTELUKAST SODIUM
    Proprietary Name Suffix n/a
    Non-Proprietary Name MONTELUKAST SODIUM
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, CHEWABLE
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name MONTELUKAST SODIUM
    Labeler Name Preferred Pharmaceuticals, Inc.
    Pharmaceutical Class Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203328
    Listing Certified Through 2023-12-31

    Package

    NDC 68788-7668-04 (68788766804)

    NDC Package Code 68788-7668-4
    Billing NDC 68788766804
    Package 14 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-4)
    Marketing Start Date 2020-02-28
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 48f21349-b66a-474d-ba2a-bd9eed04210e Details

    Revised: 9/2022