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    NDC 67544-0310-45 Spironolactone 25 mg/1 Details

    Spironolactone 25 mg/1

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

    Product Information

    NDC 67544-0310
    Product ID 67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3
    Associated GPIs 37500020000305
    GCN Sequence Number 006817
    GCN Sequence Number Description spironolactone TABLET 25 MG ORAL
    HIC3 R1H
    HIC3 Description POTASSIUM SPARING DIURETICS
    GCN 27691
    HICL Sequence Number 002901
    HICL Sequence Number Description SPIRONOLACTONE
    Brand/Generic Generic
    Proprietary Name Spironolactone
    Proprietary Name Suffix n/a
    Non-Proprietary Name spironolactone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 25
    Active Ingredient Units mg/1
    Substance Name SPIRONOLACTONE
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040424
    Listing Certified Through 2024-12-31

    Package

    NDC 67544-0310-45 (67544031045)

    NDC Package Code 67544-310-45
    Billing NDC 67544031045
    Package 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45)
    Marketing Start Date 2021-09-09
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 1c97ce61-8e49-4724-a636-d179479d346c Details

    Revised: 10/2021