Search by Drug Name or NDC

    NDC 00310-6125-92 KOMBIGLYZE 1000; 2.5 mg/1; mg/1 Details

    KOMBIGLYZE 1000; 2.5 mg/1; mg/1

    KOMBIGLYZE is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE.

    Product Information

    NDC 00310-6125
    Product ID 0310-6125_18325f97-e837-472a-9118-f1fb8b9b71e7
    Associated GPIs 27992502607520
    GCN Sequence Number 066818
    GCN Sequence Number Description saxagliptin HCl/metformin HCl TBMP 24HR 2.5-1000MG ORAL
    HIC3 C4F
    HIC3 Description ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS.
    GCN 29225
    HICL Sequence Number 037246
    HICL Sequence Number Description SAXAGLIPTIN HCL/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name KOMBIGLYZE
    Proprietary Name Suffix XR
    Non-Proprietary Name SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 1000; 2.5
    Active Ingredient Units mg/1; mg/1
    Substance Name METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
    Labeler Name AstraZeneca Pharmaceuticals LP
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA200678
    Listing Certified Through 2024-12-31

    Package

    NDC 00310-6125-92 (00310612592)

    NDC Package Code 0310-6125-92
    Billing NDC 00310612592
    Package 1 BLISTER PACK in 1 CARTON (0310-6125-92) / 12 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
    Marketing Start Date 2014-12-04
    NDC Exclude Flag N
    Pricing Information N/A