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    NDC 65862-0008-90 Metformin Hydrochloride 500 mg/1 Details

    Metformin Hydrochloride 500 mg/1

    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 METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 65862-0008
    Product ID 65862-008_c535450c-12fd-478d-ad45-743c5badfc28
    Associated GPIs 27250050000320
    GCN Sequence Number 013318
    GCN Sequence Number Description metformin HCl TABLET 500 MG ORAL
    HIC3 C4L
    HIC3 Description ANTIHYPERGLYCEMIC, BIGUANIDE TYPE
    GCN 10810
    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, FILM COATED
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units mg/1
    Substance Name METFORMIN HYDROCHLORIDE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077095
    Listing Certified Through 2025-12-31

    Package

    NDC 65862-0008-90 (65862000890)

    NDC Package Code 65862-008-90
    Billing NDC 65862000890
    Package 90 TABLET, FILM COATED in 1 BOTTLE (65862-008-90)
    Marketing Start Date 2005-01-14
    NDC Exclude Flag N
    Pricing Information N/A