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    NDC 00597-0390-31 Trijardy XR 25; 5; 1000 mg/1; mg/1; mg/1 Details

    Trijardy XR 25; 5; 1000 mg/1; mg/1; mg/1

    Trijardy XR is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 00597-0390
    Product ID 0597-0390_0cc7f716-30ec-497c-9aa0-4bfbf8b88d3e
    Associated GPIs 27996703407540
    GCN Sequence Number 080713
    GCN Sequence Number Description empaglifloz/linaglip/metformin TAB BP 24H 25-5-1000 ORAL
    HIC3 C4Y
    HIC3 Description ANTIHYPERGLY-SGLT-2 INHIB,DPP-4 INHIB,BIGUANIDE CB
    GCN 47673
    HICL Sequence Number 046321
    HICL Sequence Number Description EMPAGLIFLOZIN/LINAGLIPTIN/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name Trijardy XR
    Proprietary Name Suffix n/a
    Non-Proprietary Name empagliflozin, linagliptin, metformin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 25; 5; 1000
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
    Labeler Name Boehringer Ingelheim Pharmaceuticals, Inc.
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA212614
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0390-31 (00597039031)

    NDC Package Code 0597-0390-31
    Billing NDC 00597039031
    Package 1 BOTTLE in 1 CARTON (0597-0390-31) / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE
    Marketing Start Date 2020-04-23
    NDC Exclude Flag N
    Pricing Information N/A