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    NDC 00093-5506-56 Olanzapine and Fluoxetine 25; 12 mg/1; mg/1 Details

    Olanzapine and Fluoxetine 25; 12 mg/1; mg/1

    Olanzapine and Fluoxetine is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Pharmaceuticals USA, Inc.. The primary component is FLUOXETINE HYDROCHLORIDE; OLANZAPINE.

    Product Information

    NDC 00093-5506
    Product ID 0093-5506_35088d37-bd8c-49c4-8d1f-d3cb238f6ea0
    Associated GPIs 62995002500140
    GCN Sequence Number 053402
    GCN Sequence Number Description olanzapine/fluoxetine HCl CAPSULE 12MG-25MG ORAL
    HIC3 H7Z
    HIC3 Description SSRI-ANTIPSYCH, ATYPICAL,DOPAMINE,SEROTONIN ANTAG
    GCN 20870
    HICL Sequence Number 025800
    HICL Sequence Number Description OLANZAPINE/FLUOXETINE HCL
    Brand/Generic Generic
    Proprietary Name Olanzapine and Fluoxetine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Olanzapine and Fluoxetine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 25; 12
    Active Ingredient Units mg/1; mg/1
    Substance Name FLUOXETINE HYDROCHLORIDE; OLANZAPINE
    Labeler Name Teva Pharmaceuticals USA, Inc.
    Pharmaceutical Class Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077528
    Listing Certified Through 2024-12-31

    Package

    NDC 00093-5506-56 (00093550656)

    NDC Package Code 0093-5506-56
    Billing NDC 00093550656
    Package 30 CAPSULE in 1 BOTTLE (0093-5506-56)
    Marketing Start Date 2012-06-19
    NDC Exclude Flag N
    Pricing Information N/A