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    NDC 81522-0938-04 Ibuprofen 100 mg/5mL Details

    Ibuprofen 100 mg/5mL

    Ibuprofen is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store Inc. (Caring Mills). The primary component is IBUPROFEN.

    Product Information

    NDC 81522-0938
    Product ID 81522-938_4d5620e3-33b4-411a-9b19-561762e312f5
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Ibuprofen
    Proprietary Name Suffix Childrens
    Non-Proprietary Name Ibuprofen
    Product Type HUMAN OTC DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/5mL
    Substance Name IBUPROFEN
    Labeler Name FSA Store Inc. (Caring Mills)
    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 ANDA074916
    Listing Certified Through 2024-12-31

    Package

    NDC 81522-0938-04 (81522093804)

    NDC Package Code 81522-938-04
    Billing NDC 81522093804
    Package 1 BOTTLE in 1 CARTON (81522-938-04) / 118 mL in 1 BOTTLE
    Marketing Start Date 2022-04-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e304f791-755d-4d11-a9f6-3d46ec84197f Details

    Revised: 4/2022