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    NDC 16729-0474-03 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 Accord Healthcare, Inc.,. The primary component is GLYCOPYRROLATE.

    Product Information

    NDC 16729-0474
    Product ID 16729-474_d393a343-b672-2587-e053-2995a90a3f5b
    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
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 0.2
    Active Ingredient Units mg/mL
    Substance Name GLYCOPYRROLATE
    Labeler Name Accord Healthcare, Inc.,
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213238
    Listing Certified Through 2024-12-31

    Package

    NDC 16729-0474-03 (16729047403)

    NDC Package Code 16729-474-03
    Billing NDC 16729047403
    Package 10 VIAL, MULTI-DOSE in 1 CARTON (16729-474-03) / 20 mL in 1 VIAL, MULTI-DOSE
    Marketing Start Date 2020-12-10
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 871797f0-697a-4a29-a37b-d06219e8f266 Details

    Revised: 12/2021