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    NDC 43353-0931-09 Metolazone 5 mg/1 Details

    Metolazone 5 mg/1

    Metolazone 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 METOLAZONE.

    Product Information

    NDC 43353-0931
    Product ID 43353-931_5e3b0779-f81b-410e-820e-5cd76dad6bf5
    Associated GPIs 37600060000310
    GCN Sequence Number 008218
    GCN Sequence Number Description metolazone TABLET 5 MG ORAL
    HIC3 R1F
    HIC3 Description THIAZIDE AND RELATED DIURETICS
    GCN 34992
    HICL Sequence Number 003663
    HICL Sequence Number Description METOLAZONE
    Brand/Generic Generic
    Proprietary Name Metolazone
    Proprietary Name Suffix n/a
    Non-Proprietary Name metolazone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name METOLAZONE
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076698
    Listing Certified Through 2024-12-31

    Package

    NDC 43353-0931-09 (43353093109)

    NDC Package Code 43353-931-09
    Billing NDC 43353093109
    Package 9000 TABLET in 1 BOTTLE, PLASTIC (43353-931-09)
    Marketing Start Date 2014-04-24
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 80500d09-e1c5-450a-9806-f4f13843229d Details

    Revised: 12/2017