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    NDC 69097-0851-07 Naproxen 375 mg/1 Details

    Naproxen 375 mg/1

    Naproxen is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is NAPROXEN.

    Product Information

    NDC 69097-0851
    Product ID 69097-851_dcfba184-4397-4934-9392-2ac42f65e9e5
    Associated GPIs 66100060000610
    GCN Sequence Number 018435
    GCN Sequence Number Description naproxen TABLET DR 375 MG ORAL
    HIC3 S2B
    HIC3 Description NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
    GCN 61850
    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, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 375
    Active Ingredient Units mg/1
    Substance Name NAPROXEN
    Labeler Name Cipla USA 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 ANDA091432
    Listing Certified Through 2024-12-31

    Package

    NDC 69097-0851-07 (69097085107)

    NDC Package Code 69097-851-07
    Billing NDC 69097085107
    Package 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69097-851-07)
    Marketing Start Date 2016-07-05
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e06c2b43-9882-442e-8413-10d9a33aecb9 Details

    Revised: 8/2019