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    NDC 00310-6270-95 XIGDUO 10; 500 mg/1; mg/1 Details

    XIGDUO 10; 500 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 00310-6270
    Product ID 0310-6270_7d19a7d8-7419-4bf1-8462-52894fe73902
    Associated GPIs 27996002307520
    GCN Sequence Number 073030
    GCN Sequence Number Description dapaglifloz propaned/metformin TAB BP 24H 10MG-500MG ORAL
    HIC3 C4E
    HIC3 Description ANTIHYPERGLYCEMIC-SGLT2 INHIBITOR-BIGUANIDE COMBS.
    GCN 37342
    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 10; 500
    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 00310-6270-95 (00310627095)

    NDC Package Code 0310-6270-95
    Billing NDC 00310627095
    Package 1 BLISTER PACK in 1 CARTON (0310-6270-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
    Marketing Start Date 2014-11-11
    NDC Exclude Flag N
    Pricing Information N/A