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    NDC 53746-0190-05 Naproxen 500 mg/1 Details

    Naproxen 500 mg/1

    Naproxen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is NAPROXEN.

    Product Information

    NDC 53746-0190
    Product ID 53746-190_a107976d-f1e2-4d47-b1e0-5b961c1c8d2d
    Associated GPIs 66100060000315
    GCN Sequence Number 008362
    GCN Sequence Number Description naproxen TABLET 500 MG ORAL
    HIC3 S2B
    HIC3 Description NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
    GCN 35793
    HICL Sequence Number 003727
    HICL Sequence Number Description NAPROXEN
    Brand/Generic Generic
    Proprietary Name Naproxen
    Proprietary Name Suffix n/a
    Non-Proprietary Name Naproxen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units mg/1
    Substance Name NAPROXEN
    Labeler Name Amneal Pharmaceuticals of New York LLC
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075927
    Listing Certified Through 2024-12-31

    Package

    NDC 53746-0190-05 (53746019005)

    NDC Package Code 53746-190-05
    Billing NDC 53746019005
    Package 500 TABLET in 1 BOTTLE (53746-190-05)
    Marketing Start Date 2010-02-18
    NDC Exclude Flag N
    Pricing Information N/A