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    NDC 00517-4620-25 Glycopyrrolate 0.2 mg/mL Details

    Glycopyrrolate 0.2 mg/mL

    Glycopyrrolate is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is GLYCOPYRROLATE.

    Product Information

    NDC 00517-4620
    Product ID 0517-4620_0ac91c4c-256f-48ea-83c5-f23c56f5428f
    Associated GPIs 49102030002014
    GCN Sequence Number 004886
    GCN Sequence Number Description glycopyrrolate VIAL 0.2 MG/ML INJECTION
    HIC3 J2B
    HIC3 Description ANTICHOLINERGICS,QUATERNARY AMMONIUM
    GCN 19121
    HICL Sequence Number 002028
    HICL Sequence Number Description GLYCOPYRROLATE
    Brand/Generic Generic
    Proprietary Name Glycopyrrolate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Glycopyrrolate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 0.2
    Active Ingredient Units mg/mL
    Substance Name GLYCOPYRROLATE
    Labeler Name American Regent, Inc.
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA089335
    Listing Certified Through 2024-12-31

    Package

    NDC 00517-4620-25 (00517462025)

    NDC Package Code 0517-4620-25
    Billing NDC 00517462025
    Package 25 VIAL, MULTI-DOSE in 1 TRAY (0517-4620-25) / 20 mL in 1 VIAL, MULTI-DOSE
    Marketing Start Date 1990-09-30
    NDC Exclude Flag N
    Pricing Information N/A