NDC 0310-6770

QTERN

Dapagliflozin And Saxagliptin

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 ID0310-6770_49e0634f-e72d-4c07-8336-d197048e78ba
NDC0310-6770
Product TypeHuman Prescription Drug
Proprietary NameQTERN
Generic NameDapagliflozin And Saxagliptin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-04
Marketing CategoryNDA / NDA
Application NumberNDA209091
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameDAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0310-6770-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-6770-30 [00310677030]

QTERN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209091
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-17

NDC 0310-6770-95 [00310677095]

QTERN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209091
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
DAPAGLIFLOZIN5 mg/1

OpenFDA Data

SPL SET ID:423c489c-085b-4320-b892-7868ebd6dc6b
Manufacturer
UNII
UPC Code
  • 0303106770304
  • Pharmacological Class

    • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
    • Sodium-Glucose Transporter 2 Inhibitors [MoA]
    • Dipeptidyl Peptidase 4 Inhibitor [EPC]
    • Dipeptidyl Peptidase 4 Inhibitors [MoA]

    NDC Crossover Matching brand name "QTERN" or generic name "Dapagliflozin And Saxagliptin"

    NDCBrand NameGeneric Name
    0310-6770QTERNdapagliflozin and saxagliptin
    0310-6780QTERNdapagliflozin and saxagliptin

    Trademark Results [QTERN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    QTERN
    QTERN
    86344649 4816032 Live/Registered
    AstraZeneca AB
    2014-07-22

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