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    NDC 00378-8177-93 Saxagliptin and Metformin 1000; 5 mg/1; mg/1 Details

    Saxagliptin and Metformin 1000; 5 mg/1; mg/1

    Saxagliptin and Metformin is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE.

    Product Information

    NDC 00378-8177
    Product ID 0378-8177_0db8da29-f062-47cd-958f-6b64a6da1d84
    Associated GPIs
    GCN Sequence Number 066817
    GCN Sequence Number Description saxagliptin HCl/metformin HCl TBMP 24HR 5MG-1000MG ORAL
    HIC3 C4F
    HIC3 Description ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS.
    GCN 29224
    HICL Sequence Number 037246
    HICL Sequence Number Description SAXAGLIPTIN HCL/METFORMIN HCL
    Brand/Generic Generic
    Proprietary Name Saxagliptin and Metformin
    Proprietary Name Suffix n/a
    Non-Proprietary Name saxagliptin and metformin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 1000; 5
    Active Ingredient Units mg/1; mg/1
    Substance Name METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
    Labeler Name Mylan Pharmaceuticals Inc.
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205981
    Listing Certified Through 2024-12-31

    Package

    NDC 00378-8177-93 (00378817793)

    NDC Package Code 0378-8177-93
    Billing NDC 00378817793
    Package 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8177-93)
    Marketing Start Date 2023-08-08
    NDC Exclude Flag N
    Pricing Information N/A