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    NDC 00597-0175-66 Synjardy 5; 1000 mg/1; mg/1 Details

    Synjardy 5; 1000 mg/1; mg/1

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

    Product Information

    NDC 00597-0175
    Product ID 0597-0175_5e0b91aa-b43b-4e0f-b3ad-9b69b47433b2
    Associated GPIs 27996002400315
    GCN Sequence Number 074316
    GCN Sequence Number Description empagliflozin/metformin HCl TABLET 5MG-1000MG ORAL
    HIC3 C4E
    HIC3 Description ANTIHYPERGLYCEMIC-SGLT2 INHIBITOR-BIGUANIDE COMBS.
    GCN 38929
    HICL Sequence Number 042183
    HICL Sequence Number Description EMPAGLIFLOZIN/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name Synjardy
    Proprietary Name Suffix n/a
    Non-Proprietary Name empagliflozin and metformin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 5; 1000
    Active Ingredient Units mg/1; mg/1
    Substance Name EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
    Labeler Name Boehringer Ingelheim Pharmaceuticals, Inc.
    Pharmaceutical Class Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA206111
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0175-66 (00597017566)

    NDC Package Code 0597-0175-66
    Billing NDC 00597017566
    Package 1 BOTTLE in 1 CARTON (0597-0175-66) / 14 TABLET in 1 BOTTLE
    Marketing Start Date 2015-09-12
    NDC Exclude Flag N
    Pricing Information N/A