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    NDC 00310-6770-30 QTERN 5; 5 mg/1; mg/1 Details

    QTERN 5; 5 mg/1; mg/1

    QTERN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE.

    Product Information

    NDC 00310-6770
    Product ID 0310-6770_73713238-3794-4c37-be41-34e790e2111f
    Associated GPIs 27996502200320
    GCN Sequence Number 079873
    GCN Sequence Number Description dapagliflozin/saxagliptin HCl TABLET 5 MG-5 MG ORAL
    HIC3 C4W
    HIC3 Description ANTIHYPERGLYCEMIC, SGLT-2 AND DPP-4 INHIBITOR COMB
    GCN 46474
    HICL Sequence Number 043957
    HICL Sequence Number Description DAPAGLIFLOZIN PROPANEDIOL/SAXAGLIPTIN HCL
    Brand/Generic Brand
    Proprietary Name QTERN
    Proprietary Name Suffix n/a
    Non-Proprietary Name dapagliflozin and saxagliptin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5; 5
    Active Ingredient Units mg/1; mg/1
    Substance Name DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
    Labeler Name AstraZeneca Pharmaceuticals LP
    Pharmaceutical Class Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA209091
    Listing Certified Through 2024-12-31

    Package

    NDC 00310-6770-30 (00310677030)

    NDC Package Code 0310-6770-30
    Billing NDC 00310677030
    Package 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)
    Marketing Start Date 2019-06-17
    NDC Exclude Flag N
    Pricing Information N/A