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    NDC 65862-0032-05 Mirtazapine 45 mg/1 Details

    Mirtazapine 45 mg/1

    Mirtazapine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is MIRTAZAPINE.

    Product Information

    NDC 65862-0032
    Product ID 65862-032_fbb7592b-2145-49b3-80af-f4710c07c9ff
    Associated GPIs 58030050000345
    GCN Sequence Number 046452
    GCN Sequence Number Description mirtazapine TABLET 45 MG ORAL
    HIC3 H7B
    HIC3 Description ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS
    GCN 16734
    HICL Sequence Number 011505
    HICL Sequence Number Description MIRTAZAPINE
    Brand/Generic Generic
    Proprietary Name Mirtazapine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Mirtazapine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 45
    Active Ingredient Units mg/1
    Substance Name MIRTAZAPINE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076921
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0032-05 (65862003205)

    NDC Package Code 65862-032-05
    Billing NDC 65862003205
    Package 500 TABLET, FILM COATED in 1 BOTTLE (65862-032-05)
    Marketing Start Date 2004-10-22
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a4c012f0-50b6-42fb-9f06-a14632f23f2e Details

    Revised: 12/2021