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    NDC 49483-0609-00 NAPROXEN SODIUM 220 mg/1 Details

    NAPROXEN SODIUM 220 mg/1

    NAPROXEN SODIUM is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC. The primary component is NAPROXEN SODIUM.

    Product Information

    NDC 49483-0609
    Product ID 49483-609_cbf198fe-25e4-694c-e053-2995a90aae22
    Associated GPIs 66100060100303
    GCN Sequence Number 021980
    GCN Sequence Number Description naproxen sodium TABLET 220 MG ORAL
    HIC3 S2B
    HIC3 Description NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
    GCN 47132
    HICL Sequence Number 003726
    HICL Sequence Number Description NAPROXEN SODIUM
    Brand/Generic Generic
    Proprietary Name NAPROXEN SODIUM
    Proprietary Name Suffix n/a
    Non-Proprietary Name NAPROXEN SODIUM
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 220
    Active Ingredient Units mg/1
    Substance Name NAPROXEN SODIUM
    Labeler Name TIME CAP LABORATORIES, 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 ANDA090545
    Listing Certified Through 2024-12-31

    Package

    NDC 49483-0609-00 (49483060900)

    NDC Package Code 49483-609-00
    Billing NDC 49483060900
    Package 6500 TABLET, FILM COATED in 1 BAG (49483-609-00)
    Marketing Start Date 2016-03-28
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 17ecaee0-c1c6-4360-81c1-d6afe50b9b27 Details

    Revised: 12/2021