Search by Drug Name or NDC

    NDC 61919-0448-90 GLIMEPIRIDE 2 mg/1 Details

    GLIMEPIRIDE 2 mg/1

    GLIMEPIRIDE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dircet_Rx. The primary component is GLIMEPIRIDE.

    Product Information

    NDC 61919-0448
    Product ID 61919-448_d61cab38-675c-37ab-e053-2a95a90a4f91
    Associated GPIs 27200027000320
    GCN Sequence Number 025180
    GCN Sequence Number Description glimepiride TABLET 2 MG ORAL
    HIC3 C4K
    HIC3 Description ANTIHYPERGLYCEMIC, INSULIN-RELEASE STIMULANT TYPE
    GCN 05832
    HICL Sequence Number 010485
    HICL Sequence Number Description GLIMEPIRIDE
    Brand/Generic Generic
    Proprietary Name GLIMEPIRIDE
    Proprietary Name Suffix n/a
    Non-Proprietary Name GLIMEPIRIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 2
    Active Ingredient Units mg/1
    Substance Name GLIMEPIRIDE
    Labeler Name Dircet_Rx
    Pharmaceutical Class Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078181
    Listing Certified Through 2023-12-31

    Package

    NDC 61919-0448-90 (61919044890)

    NDC Package Code 61919-448-90
    Billing NDC 61919044890
    Package 90 TABLET in 1 BOTTLE (61919-448-90)
    Marketing Start Date 2019-08-08
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 8f9c8db3-81a1-35ec-e053-2995a90a8c83 Details

    Revised: 1/2022