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    NDC 71610-0177-09 Jardiance 25 mg/1 Details

    Jardiance 25 mg/1

    Jardiance is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is EMPAGLIFLOZIN.

    Product Information

    NDC 71610-0177
    Product ID 71610-177_75491ff1-aa83-4d04-89ad-1137b2838e7a
    Associated GPIs 27700050000320
    GCN Sequence Number 072489
    GCN Sequence Number Description empagliflozin TABLET 25 MG ORAL
    HIC3 C4D
    HIC3 Description ANTIHYPERGLYCEMIC-SOD/GLUC COTRANSPORT2(SGLT2) INH
    GCN 36723
    HICL Sequence Number 041217
    HICL Sequence Number Description EMPAGLIFLOZIN
    Brand/Generic Generic
    Proprietary Name Jardiance
    Proprietary Name Suffix n/a
    Non-Proprietary Name Empagliflozin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 25
    Active Ingredient Units mg/1
    Substance Name EMPAGLIFLOZIN
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA204629
    Listing Certified Through 2024-12-31

    Package

    NDC 71610-0177-09 (71610017709)

    NDC Package Code 71610-177-09
    Billing NDC 71610017709
    Package 9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09)
    Marketing Start Date 2018-10-24
    NDC Exclude Flag N
    Pricing Information N/A