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    NDC 67544-0019-53 Diazepam 5 mg/1 Details

    Diazepam 5 mg/1

    Diazepam 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 DIAZEPAM.

    Product Information

    NDC 67544-0019
    Product ID 67544-019_fe566d09-3b52-4def-901e-a14f3589f799
    Associated GPIs 57100040000310
    GCN Sequence Number 003768
    GCN Sequence Number Description diazepam TABLET 5 MG ORAL
    HIC3 H20
    HIC3 Description ANTI-ANXIETY - BENZODIAZEPINES
    GCN 14222
    HICL Sequence Number 001615
    HICL Sequence Number Description DIAZEPAM
    Brand/Generic Generic
    Proprietary Name Diazepam
    Proprietary Name Suffix n/a
    Non-Proprietary Name Diazepam
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name DIAZEPAM
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Benzodiazepine [EPC], Benzodiazepines [CS]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA071135
    Listing Certified Through 2024-12-31

    Package

    NDC 67544-0019-53 (67544001953)

    NDC Package Code 67544-019-53
    Billing NDC 67544001953
    Package 60 TABLET in 1 BOTTLE, PLASTIC (67544-019-53)
    Marketing Start Date 2006-03-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 620bdaf4-3003-4a54-a711-1d360553e211 Details

    Revised: 12/2017