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    NDC 15955-0389-05 Metronidazole 500 mg/1 Details

    Metronidazole 500 mg/1

    Metronidazole is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alembic Labs LLC. The primary component is METRONIDAZOLE.

    Product Information

    NDC 15955-0389
    Product ID 15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Metronidazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name Metronidazole
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units mg/1
    Substance Name METRONIDAZOLE
    Labeler Name Alembic Labs LLC
    Pharmaceutical Class Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208681
    Listing Certified Through 2024-12-31

    Package

    NDC 15955-0389-05 (15955038905)

    NDC Package Code 15955-389-05
    Billing NDC 15955038905
    Package 500 TABLET in 1 BOTTLE (15955-389-05)
    Marketing Start Date 2019-06-26
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 86415209-5440-41da-abb8-e1a3d5051f91 Details

    Revised: 6/2022