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    NDC 49035-0635-09 Concentrated ibuprofen infants 50 mg/1.25mL Details

    Concentrated ibuprofen infants 50 mg/1.25mL

    Concentrated ibuprofen infants is a ORAL SUSPENSION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is IBUPROFEN.

    Product Information

    NDC 49035-0635
    Product ID 49035-635_ad449225-ed60-4c66-9fd6-34bef9a4b42e
    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 Concentrated ibuprofen infants
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ibuprofen
    Product Type HUMAN OTC DRUG
    Dosage Form SUSPENSION/ DROPS
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1.25mL
    Substance Name IBUPROFEN
    Labeler Name Wal-Mart Stores, 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 ANDA210755
    Listing Certified Through 2024-12-31

    Package

    NDC 49035-0635-09 (49035063509)

    NDC Package Code 49035-635-09
    Billing NDC 49035063509
    Package 1 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLE
    Marketing Start Date 2019-06-20
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 00b7fc71-8cf0-4c12-a479-146408f7f91b Details

    Revised: 1/2022