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    NDC 50580-0563-80 Motrin 38; 200 mg/1; mg/1 Details

    Motrin 38; 200 mg/1; mg/1

    Motrin is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is DIPHENHYDRAMINE CITRATE; IBUPROFEN.

    Product Information

    NDC 50580-0563
    Product ID 50580-563_f7db3163-4f91-c5db-e053-6394a90a5b70
    Associated GPIs
    GCN Sequence Number 062493
    GCN Sequence Number Description ibuprofen/diphenhydramine cit TABLET 200MG-38MG ORAL
    HIC3 S2S
    HIC3 Description ANALGESIC,NSAID-1ST GEN.ANTIHISTAMINE,SEDATIVE CMB
    GCN 98268
    HICL Sequence Number 034634
    HICL Sequence Number Description IBUPROFEN/DIPHENHYDRAMINE CITRATE
    Brand/Generic Generic
    Proprietary Name Motrin
    Proprietary Name Suffix PM
    Non-Proprietary Name Ibuprofen and Diphenhydramine Citrate
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 38; 200
    Active Ingredient Units mg/1; mg/1
    Substance Name DIPHENHYDRAMINE CITRATE; IBUPROFEN
    Labeler Name Johnson & Johnson Consumer Inc.
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA079113
    Listing Certified Through 2024-12-31

    Package

    NDC 50580-0563-80 (50580056380)

    NDC Package Code 50580-563-80
    Billing NDC 50580056380
    Package 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
    Marketing Start Date 2010-01-11
    NDC Exclude Flag N
    Pricing Information N/A