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    NDC 80725-0388-13 Coreg CR 80 mg/1 Details

    Coreg CR 80 mg/1

    Coreg CR is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Waylis Therapeutics LLC. The primary component is CARVEDILOL PHOSPHATE.

    Product Information

    NDC 80725-0388
    Product ID 80725-388_9376abd9-c71f-4036-b69f-98bf95fdeb9d
    Associated GPIs
    GCN Sequence Number 061814
    GCN Sequence Number Description carvedilol phosphate CPMP 24HR 80 MG ORAL
    HIC3 J7A
    HIC3 Description ALPHA/BETA-ADRENERGIC BLOCKING AGENTS
    GCN 97599
    HICL Sequence Number 034245
    HICL Sequence Number Description CARVEDILOL PHOSPHATE
    Brand/Generic Brand
    Proprietary Name Coreg CR
    Proprietary Name Suffix n/a
    Non-Proprietary Name Carvedilol Phosphate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 80
    Active Ingredient Units mg/1
    Substance Name CARVEDILOL PHOSPHATE
    Labeler Name Waylis Therapeutics LLC
    Pharmaceutical Class Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022012
    Listing Certified Through 2024-12-31

    Package

    NDC 80725-0388-13 (80725038813)

    NDC Package Code 80725-388-13
    Billing NDC 80725038813
    Package 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-388-13)
    Marketing Start Date 2022-11-07
    NDC Exclude Flag N
    Pricing Information N/A