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    NDC 68382-0385-14 Duloxetine 20 mg/1 Details

    Duloxetine 20 mg/1

    Duloxetine is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals (USA) Inc.. The primary component is DULOXETINE HYDROCHLORIDE.

    Product Information

    NDC 68382-0385
    Product ID 68382-385_f95fe0a8-5492-4210-87a3-1881b4e98372
    Associated GPIs 58180025106720
    GCN Sequence Number 057891
    GCN Sequence Number Description duloxetine HCl CAPSULE DR 20 MG ORAL
    HIC3 H7C
    HIC3 Description SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS)
    GCN 23161
    HICL Sequence Number 026521
    HICL Sequence Number Description DULOXETINE HCL
    Brand/Generic Generic
    Proprietary Name Duloxetine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Duloxetine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/1
    Substance Name DULOXETINE HYDROCHLORIDE
    Labeler Name Zydus Pharmaceuticals (USA) Inc.
    Pharmaceutical Class Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090739
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0385-14 (68382038514)

    NDC Package Code 68382-385-14
    Billing NDC 68382038514
    Package 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-385-14)
    Marketing Start Date 2014-05-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 9e20ba52-19bb-4683-b6ec-293b54f45898 Details

    Revised: 10/2020