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    NDC 68382-0185-10 Glipizide and Metformin Hydrochloride 2.5; 500 mg/1; mg/1 Details

    Glipizide and Metformin Hydrochloride 2.5; 500 mg/1; mg/1

    Glipizide and Metformin Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is GLIPIZIDE; METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 68382-0185
    Product ID 68382-185_6a952de4-8cf7-4c86-87a3-8054c6993288
    Associated GPIs 27997002350325
    GCN Sequence Number 051195
    GCN Sequence Number Description glipizide/metformin HCl TABLET 2.5-500 MG ORAL
    HIC3 C4S
    HIC3 Description ANTIHYPERGLYCEMIC,INSULIN-RELEASE STIM.-BIGUANIDE
    GCN 18367
    HICL Sequence Number 024429
    HICL Sequence Number Description GLIPIZIDE/METFORMIN HCL
    Brand/Generic Generic
    Proprietary Name Glipizide and Metformin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Glipizide and Metformin Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 2.5; 500
    Active Ingredient Units mg/1; mg/1
    Substance Name GLIPIZIDE; METFORMIN HYDROCHLORIDE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078905
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0185-10 (68382018510)

    NDC Package Code 68382-185-10
    Billing NDC 68382018510
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (68382-185-10)
    Marketing Start Date 2016-05-05
    NDC Exclude Flag N
    Pricing Information N/A