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    NDC 63629-8989-02 fluoxetine hydrochloride 10 mg/1 Details

    fluoxetine hydrochloride 10 mg/1

    fluoxetine hydrochloride is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is FLUOXETINE HYDROCHLORIDE.

    Product Information

    NDC 63629-8989
    Product ID 63629-8989_a168e3e4-6451-4439-913d-c88181932786
    Associated GPIs 58160040000310
    GCN Sequence Number 046216
    GCN Sequence Number Description fluoxetine HCl TABLET 10 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 16356
    HICL Sequence Number 001655
    HICL Sequence Number Description FLUOXETINE HCL
    Brand/Generic Generic
    Proprietary Name fluoxetine hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name fluoxetine hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name FLUOXETINE HYDROCHLORIDE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203836
    Listing Certified Through 2024-12-31

    Package

    NDC 63629-8989-02 (63629898902)

    NDC Package Code 63629-8989-2
    Billing NDC 63629898902
    Package 90 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-2)
    Marketing Start Date 2021-12-07
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 80816531-9db3-492b-aebc-4681bf3c1554 Details

    Revised: 12/2021