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    NDC 00574-1133-16 SPIRONOLACTONE 25 mg/5mL Details

    SPIRONOLACTONE 25 mg/5mL

    SPIRONOLACTONE is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis US LLC. The primary component is SPIRONOLACTONE.

    Product Information

    NDC 00574-1133
    Product ID 0574-1133_522bd365-ddcc-48f4-8a98-66dc4c3bb314
    Associated GPIs
    GCN Sequence Number 046605
    GCN Sequence Number Description spironolactone ORAL SUSP 25 MG/5 ML ORAL
    HIC3 R1H
    HIC3 Description POTASSIUM SPARING DIURETICS
    GCN 15596
    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 SUSPENSION
    Route ORAL
    Active Ingredient Strength 25
    Active Ingredient Units mg/5mL
    Substance Name SPIRONOLACTONE
    Labeler Name Padagis US LLC
    Pharmaceutical Class Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA AUTHORIZED GENERIC
    Application Number NDA209478
    Listing Certified Through 2024-12-31

    Package

    NDC 00574-1133-16 (00574113316)

    NDC Package Code 0574-1133-16
    Billing NDC 00574113316
    Package 473 mL in 1 BOTTLE (0574-1133-16)
    Marketing Start Date 2023-10-31
    NDC Exclude Flag N
    Pricing Information N/A