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    NDC 63629-8990-01 fluoxetine hydrochloride 20 mg/1 Details

    fluoxetine hydrochloride 20 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 63629-8990
    Product ID 63629-8990_dd12db56-8fc2-4a97-bc73-a00d0c5ec245
    Associated GPIs 58160040000320
    GCN Sequence Number 046219
    GCN Sequence Number Description fluoxetine HCl TABLET 20 MG ORAL
    HIC3 H2S
    HIC3 Description SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS)
    GCN 16359
    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 20
    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 63629-8990-01 (63629899001)

    NDC Package Code 63629-8990-1
    Billing NDC 63629899001
    Package 60 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8990-1)
    Marketing Start Date 2021-12-07
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL da785a8a-d897-494e-9fd2-1d09b32f0190 Details

    Revised: 12/2021