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    NDC 58602-0003-24 CHILDRENS IBUPROFEN 100 mg/5mL Details

    CHILDRENS IBUPROFEN 100 mg/5mL

    CHILDRENS IBUPROFEN is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is IBUPROFEN.

    Product Information

    NDC 58602-0003
    Product ID 58602-003_0e1bcb06-be48-4efc-82e2-516582e02348
    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 CHILDRENS IBUPROFEN
    Proprietary Name Suffix n/a
    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 Aurohealth 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 ANDA209179
    Listing Certified Through 2024-12-31

    Package

    NDC 58602-0003-24 (58602000324)

    NDC Package Code 58602-003-24
    Billing NDC 58602000324
    Package 1 BOTTLE in 1 CARTON (58602-003-24) / 120 mL in 1 BOTTLE
    Marketing Start Date 2021-06-16
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 0e1bcb06-be48-4efc-82e2-516582e02348 Details

    Revised: 6/2021