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    NDC 65862-0082-05 Glyburide and Metformin Hydrochloride 5; 500 mg/1; mg/1 Details

    Glyburide and Metformin Hydrochloride 5; 500 mg/1; mg/1

    Glyburide and Metformin Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is GLYBURIDE; METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 65862-0082
    Product ID 65862-082_fdedb669-6be4-4c45-8a09-62b767855894
    Associated GPIs 27997002400330
    GCN Sequence Number 045930
    GCN Sequence Number Description glyburide/metformin HCl TABLET 5 MG-500MG ORAL
    HIC3 C4S
    HIC3 Description ANTIHYPERGLYCEMIC,INSULIN-RELEASE STIM.-BIGUANIDE
    GCN 89879
    HICL Sequence Number 009690
    HICL Sequence Number Description GLYBURIDE/METFORMIN HCL
    Brand/Generic Generic
    Proprietary Name Glyburide and Metformin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Glyburide and Metformin Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5; 500
    Active Ingredient Units mg/1; mg/1
    Substance Name GLYBURIDE; METFORMIN HYDROCHLORIDE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077870
    Listing Certified Through 2024-12-31

    Package

    NDC 65862-0082-05 (65862008205)

    NDC Package Code 65862-082-05
    Billing NDC 65862008205
    Package 500 TABLET, FILM COATED in 1 BOTTLE (65862-082-05)
    Marketing Start Date 2007-11-14
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.0492
    Pricing Unit EA
    Effective Date 2022-11-23
    NDC Description GLYBURIDE-METFORMIN 5-500 MG
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 7010b662-8b34-49ce-8e5b-73dee0821a60 Details

    Revised: 3/2022