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    NDC 54162-0941-90 Ibuprofen 200 mg/1 Details

    Ibuprofen 200 mg/1

    Ibuprofen is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Geritrex LLC. The primary component is IBUPROFEN.

    Product Information

    NDC 54162-0941
    Product ID 54162-941_f6080edf-c278-4721-8335-4c299adf0c9e
    Associated GPIs 66100020000305
    GCN Sequence Number 008346
    GCN Sequence Number Description ibuprofen TABLET 200 MG ORAL
    HIC3 S2B
    HIC3 Description NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
    GCN 35743
    HICL Sequence Number 003723
    HICL Sequence Number Description IBUPROFEN
    Brand/Generic Generic
    Proprietary Name Ibuprofen
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ibuprofen
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name IBUPROFEN
    Labeler Name Geritrex 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 ANDA075010
    Listing Certified Through 2024-12-31

    Package

    NDC 54162-0941-90 (54162094190)

    NDC Package Code 54162-941-90
    Billing NDC 54162094190
    Package 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-90)
    Marketing Start Date 2018-10-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ca9498ec-755d-4a09-9504-210dd48d6fed Details

    Revised: 10/2018