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    NDC 66993-0361-60 dapagliflozin and metformin hydrochloride 5; 1000 mg/1; mg/1 Details

    dapagliflozin and metformin hydrochloride 5; 1000 mg/1; mg/1

    dapagliflozin and metformin hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PRASCO, LLC. The primary component is DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE.

    Product Information

    NDC 66993-0361
    Product ID 66993-361_eaf135b6-e378-4f62-a1e7-db45e23668c7
    Associated GPIs
    GCN Sequence Number 073031
    GCN Sequence Number Description dapaglifloz propaned/metformin TAB BP 24H 5MG-1000MG ORAL
    HIC3 C4E
    HIC3 Description ANTIHYPERGLYCEMIC-SGLT2 INHIBITOR-BIGUANIDE COMBS.
    GCN 37343
    HICL Sequence Number 041188
    HICL Sequence Number Description DAPAGLIFLOZIN PROPANEDIOL/METFORMIN HCL
    Brand/Generic Generic
    Proprietary Name dapagliflozin and metformin hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name dapagliflozin and metformin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 5; 1000
    Active Ingredient Units mg/1; mg/1
    Substance Name DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
    Labeler Name PRASCO, LLC
    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 AUTHORIZED GENERIC
    Application Number NDA205649
    Listing Certified Through 2025-12-31

    Package

    NDC 66993-0361-60 (66993036160)

    NDC Package Code 66993-361-60
    Billing NDC 66993036160
    Package 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)
    Marketing Start Date 2024-01-03
    NDC Exclude Flag N
    Pricing Information N/A