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    NDC 71839-0123-25 glycopyrrolate 0.2 mg/mL Details

    glycopyrrolate 0.2 mg/mL

    glycopyrrolate is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BE Pharmaceuticals Inc.. The primary component is GLYCOPYRROLATE.

    Product Information

    NDC 71839-0123
    Product ID 71839-123_d9df3900-a8c2-438b-8971-ba11ff91f90b
    Associated GPIs 49102030002010
    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
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 0.2
    Active Ingredient Units mg/mL
    Substance Name GLYCOPYRROLATE
    Labeler Name BE Pharmaceuticals Inc.
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA211705
    Listing Certified Through 2024-12-31

    Package

    NDC 71839-0123-25 (71839012325)

    NDC Package Code 71839-123-25
    Billing NDC 71839012325
    Package 25 VIAL, SINGLE-DOSE in 1 CARTON (71839-123-25) / 1 mL in 1 VIAL, SINGLE-DOSE (71839-123-01)
    Marketing Start Date 2022-03-10
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL d9df3900-a8c2-438b-8971-ba11ff91f90b Details

    Revised: 2/2022