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    NDC 70710-1645-07 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 Zydus Pharmaceuticals USA Inc.. The primary component is GLYCOPYRROLATE.

    Product Information

    NDC 70710-1645
    Product ID 70710-1645_c56593be-a843-4885-8af8-c8535654ef1d
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA214213
    Listing Certified Through 2024-12-31

    Package

    NDC 70710-1645-07 (70710164507)

    NDC Package Code 70710-1645-7
    Billing NDC 70710164507
    Package 25 VIAL in 1 CARTON (70710-1645-7) / 1 mL in 1 VIAL (70710-1645-1)
    Marketing Start Date 2021-11-18
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 90974a9f-c664-49b8-8d23-182286becc7c Details

    Revised: 11/2022