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    NDC 63187-0430-60 Montelukast Sodium 10 mg/1 Details

    Montelukast Sodium 10 mg/1

    Montelukast Sodium is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is MONTELUKAST SODIUM.

    Product Information

    NDC 63187-0430
    Product ID 63187-430_3987b125-2cd5-4cae-9009-4e839599a38e
    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 Montelukast Sodium
    Proprietary Name Suffix n/a
    Non-Proprietary Name Montelukast Sodium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name MONTELUKAST SODIUM
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201515
    Listing Certified Through 2024-12-31

    Package

    NDC 63187-0430-60 (63187043060)

    NDC Package Code 63187-430-60
    Billing NDC 63187043060
    Package 60 TABLET in 1 BOTTLE (63187-430-60)
    Marketing Start Date 2014-03-03
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 8a724790-e1fb-4935-bb28-ce99455be5ef Details

    Revised: 11/2019