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    NDC 70710-1539-09 Duloxetine 60 mg/1 Details

    Duloxetine 60 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 70710-1539
    Product ID 70710-1539_a2356703-66f4-491b-874e-d4a4a2183788
    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 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 60
    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 ANDA090728
    Listing Certified Through 2024-12-31

    Package

    NDC 70710-1539-09 (70710153909)

    NDC Package Code 70710-1539-9
    Billing NDC 70710153909
    Package 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1539-9)
    Marketing Start Date 2014-05-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2faca72c-be66-4d90-9cef-3ef79927723b Details

    Revised: 11/2022