Search by Drug Name or NDC

    NDC 68382-0658-01 glyburide 5 mg/1 Details

    glyburide 5 mg/1

    glyburide is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals (USA) Inc.. The primary component is GLYBURIDE.

    Product Information

    NDC 68382-0658
    Product ID 68382-658_1ff75368-1bfd-4173-b0aa-18eca2c97a4f
    Associated GPIs 27200040000315
    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 glyburide
    Proprietary Name Suffix n/a
    Non-Proprietary Name glyburide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name GLYBURIDE
    Labeler Name Zydus Pharmaceuticals (USA) Inc.
    Pharmaceutical Class Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206749
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0658-01 (68382065801)

    NDC Package Code 68382-658-01
    Billing NDC 68382065801
    Package 100 TABLET in 1 BOTTLE (68382-658-01)
    Marketing Start Date 2016-06-02
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 87781ea8-62ec-483c-a4dd-8c965ce59485 Details

    Revised: 11/2022