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    NDC 55111-0565-92 Ibuprofen and Diphenhydramine Citrate 38; 200 mg/1; mg/1 Details

    Ibuprofen and Diphenhydramine Citrate 38; 200 mg/1; mg/1

    Ibuprofen and Diphenhydramine Citrate is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is DIPHENHYDRAMINE CITRATE; IBUPROFEN.

    Product Information

    NDC 55111-0565
    Product ID 55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963
    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 and Diphenhydramine Citrate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ibuprofen and Diphenhydramine Citrate
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 38; 200
    Active Ingredient Units mg/1; mg/1
    Substance Name DIPHENHYDRAMINE CITRATE; IBUPROFEN
    Labeler Name Dr. Reddy's Laboratories Limited
    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 ANDA090619
    Listing Certified Through 2024-12-31

    Package

    NDC 55111-0565-92 (55111056592)

    NDC Package Code 55111-565-92
    Billing NDC 55111056592
    Package 2500 TABLET in 1 POUCH (55111-565-92)
    Marketing Start Date 2010-01-31
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 42c06daf-541a-7721-b875-ea18364501a4 Details

    Revised: 12/2018