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    NDC 00597-0300-20 Synjardy 12.5; 1000 mg/1; mg/1 Details

    Synjardy 12.5; 1000 mg/1; mg/1

    Synjardy 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; METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 00597-0300
    Product ID 0597-0300_f81d39d1-538b-491d-94a7-8d0c788e5bcf
    Associated GPIs 27996002407550
    GCN Sequence Number 076941
    GCN Sequence Number Description empagliflozin/metformin HCl TAB BP 24H 12.5-1000 ORAL
    HIC3 C4E
    HIC3 Description ANTIHYPERGLYCEMIC-SGLT2 INHIBITOR-BIGUANIDE COMBS.
    GCN 42787
    HICL Sequence Number 042183
    HICL Sequence Number Description EMPAGLIFLOZIN/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name Synjardy
    Proprietary Name Suffix XR
    Non-Proprietary Name empagliflozin, metformin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 12.5; 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 NDA208658
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0300-20 (00597030020)

    NDC Package Code 0597-0300-20
    Billing NDC 00597030020
    Package 1 BOTTLE in 1 CARTON (0597-0300-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
    Marketing Start Date 2016-12-10
    NDC Exclude Flag N
    Pricing Information N/A