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    NDC 71610-0008-80 Lorazepam 0.5 mg/1 Details

    Lorazepam 0.5 mg/1

    Lorazepam is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is LORAZEPAM.

    Product Information

    NDC 71610-0008
    Product ID 71610-008_ad63049b-9fb2-4b02-8ef4-d3b9aa3fe54b
    Associated GPIs 57100060000305
    GCN Sequence Number 003757
    GCN Sequence Number Description lorazepam TABLET 0.5 MG ORAL
    HIC3 H20
    HIC3 Description ANTI-ANXIETY - BENZODIAZEPINES
    GCN 14160
    HICL Sequence Number 004846
    HICL Sequence Number Description LORAZEPAM
    Brand/Generic Generic
    Proprietary Name Lorazepam
    Proprietary Name Suffix n/a
    Non-Proprietary Name Lorazepam
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/1
    Substance Name LORAZEPAM
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Benzodiazepine [EPC], Benzodiazepines [CS]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA078203
    Listing Certified Through 2024-12-31

    Package

    NDC 71610-0008-80 (71610000880)

    NDC Package Code 71610-008-80
    Billing NDC 71610000880
    Package 180 TABLET in 1 BOTTLE (71610-008-80)
    Marketing Start Date 2018-10-03
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e83ae439-3fa5-453f-9073-4bf8c797df47 Details

    Revised: 3/2019