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    NDC 42291-0497-01 Metformin Hydrochloride 500 mg/1 Details

    Metformin Hydrochloride 500 mg/1

    Metformin Hydrochloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 42291-0497
    Product ID 42291-497_fa2ccb14-6b86-764a-e053-6394a90ac4db
    Associated GPIs 27250050007520
    GCN Sequence Number 046754
    GCN Sequence Number Description metformin HCl TAB ER 24H 500 MG ORAL
    HIC3 C4L
    HIC3 Description ANTIHYPERGLYCEMIC, BIGUANIDE TYPE
    GCN 89863
    HICL Sequence Number 004763
    HICL Sequence Number Description METFORMIN HCL
    Brand/Generic Generic
    Proprietary Name Metformin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Metformin Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units mg/1
    Substance Name METFORMIN HYDROCHLORIDE
    Labeler Name AvKARE
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078596
    Listing Certified Through 2024-12-31

    Package

    NDC 42291-0497-01 (42291049701)

    NDC Package Code 42291-497-01
    Billing NDC 42291049701
    Package 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-01)
    Marketing Start Date 2022-03-31
    NDC Exclude Flag N
    Pricing Information N/A