Search by Drug Name or NDC

    NDC 36800-0286-03 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 TOPCO ASSOCIATES LLC. The primary component is IBUPROFEN.

    Product Information

    NDC 36800-0286
    Product ID 36800-286_ee297186-699a-dc48-e053-2995a90a266b
    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 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 TOPCO ASSOCIATES 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 ANDA202312
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0286-03 (36800028603)

    NDC Package Code 36800-286-03
    Billing NDC 36800028603
    Package 1 BOTTLE, PLASTIC in 1 CARTON (36800-286-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
    Marketing Start Date 2021-11-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL cef74c2f-0c23-609d-e053-2a95a90a6b8e Details

    Revised: 11/2022