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    NDC 70010-0138-10 Naproxen 375 mg/1 Details

    Naproxen 375 mg/1

    Naproxen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Granules Pharmaceuticals Inc.. The primary component is NAPROXEN SODIUM.

    Product Information

    NDC 70010-0138
    Product ID 70010-138_018ffdd3-bc90-fb23-e063-6394a90a3e1e
    Associated GPIs 66100060000310
    GCN Sequence Number 008361
    GCN Sequence Number Description naproxen TABLET 375 MG ORAL
    HIC3 S2B
    HIC3 Description NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
    GCN 35792
    HICL Sequence Number 003727
    HICL Sequence Number Description NAPROXEN
    Brand/Generic Generic
    Proprietary Name Naproxen
    Proprietary Name Suffix n/a
    Non-Proprietary Name Naproxen Sodium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 375
    Active Ingredient Units mg/1
    Substance Name NAPROXEN SODIUM
    Labeler Name Granules Pharmaceuticals Inc.
    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 ANDA074140
    Listing Certified Through 2024-12-31

    Package

    NDC 70010-0138-10 (70010013810)

    NDC Package Code 70010-138-10
    Billing NDC 70010013810
    Package 1000 TABLET in 1 BOTTLE (70010-138-10)
    Marketing Start Date 2021-04-15
    NDC Exclude Flag N
    Pricing Information N/A