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    NDC 64380-0732-11 IBUPROFEN AND DIPHENHYDRAMINE HCL 25; 200 mg/1; mg/1 Details

    IBUPROFEN AND DIPHENHYDRAMINE HCL 25; 200 mg/1; mg/1

    IBUPROFEN AND DIPHENHYDRAMINE HCL is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN.

    Product Information

    NDC 64380-0732
    Product ID 64380-732_2c462426-b635-44dd-b4cb-54f67afb37d9
    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 HCL
    Proprietary Name Suffix n/a
    Non-Proprietary Name IBUPROFEN AND DIPHENHYDRAMINE HCL
    Product Type HUMAN OTC DRUG
    Dosage Form CAPSULE, LIQUID FILLED
    Route ORAL
    Active Ingredient Strength 25; 200
    Active Ingredient Units mg/1; mg/1
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
    Labeler Name Strides Pharma Science 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 ANDA200888
    Listing Certified Through 2024-12-31

    Package

    NDC 64380-0732-11 (64380073211)

    NDC Package Code 64380-732-11
    Billing NDC 64380073211
    Package 1 BOTTLE, PLASTIC in 1 CARTON (64380-732-11) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
    Marketing Start Date 2016-12-28
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 10d52858-a55f-4053-aa77-da660556a2ad Details

    Revised: 2/2022