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    NDC 00310-6225-94 XIGDUO 2.5; 1000 mg/1; mg/1 Details

    XIGDUO 2.5; 1000 mg/1; mg/1

    XIGDUO 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 DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 00310-6225
    Product ID 0310-6225_7d19a7d8-7419-4bf1-8462-52894fe73902
    Associated GPIs 27996002307507
    GCN Sequence Number 078062
    GCN Sequence Number Description dapaglifloz propaned/metformin TAB BP 24H 2.5-1000MG ORAL
    HIC3 C4E
    HIC3 Description ANTIHYPERGLYCEMIC-SGLT2 INHIBITOR-BIGUANIDE COMBS.
    GCN 44304
    HICL Sequence Number 041188
    HICL Sequence Number Description DAPAGLIFLOZIN PROPANEDIOL/METFORMIN HCL
    Brand/Generic Brand
    Proprietary Name XIGDUO
    Proprietary Name Suffix XR
    Non-Proprietary Name dapagliflozin and metformin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 2.5; 1000
    Active Ingredient Units mg/1; mg/1
    Substance Name DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
    Labeler Name AstraZeneca Pharmaceuticals LP
    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 NDA205649
    Listing Certified Through 2024-12-31

    Package

    NDC 00310-6225-94 (00310622594)

    NDC Package Code 0310-6225-94
    Billing NDC 00310622594
    Package 1 BLISTER PACK in 1 CARTON (0310-6225-94) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
    Marketing Start Date 2018-01-15
    NDC Exclude Flag N
    Pricing Information N/A