NDC 0310-6780

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 ID: 0310-6780_004691c3-02f4-4d9e-abfd-ec3c003537b1
• NDC: 0310-6780
• Product Type: Human Prescription Drug
• Proprietary Name: QTERN
• Generic Name: Dapagliflozin And Saxagliptin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-04
• Marketing Category: NDA / NDA
• Application Number: NDA209091
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0310-6780-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-6780-30)

• Marketing Start Date: 2017-12-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6780-95 [00310678095]

QTERN TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209091
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-04

NDC 0310-6780-30 [00310678030]

QTERN TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209091
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-04

Drug Details

Active Ingredients

Ingredient	Strength
DAPAGLIFLOZIN	10 mg/1

OpenFDA Data

• SPL SET ID: 423c489c-085b-4320-b892-7868ebd6dc6b
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • Z8J84YIX6L
  • 1ULL0QJ8UC
• RxNorm Concept Unique ID - RxCUI:
  • 1925498
  • 1925504
• UPC Code:
  • 0303106780303

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"

NDC	Brand Name	Generic Name
0310-6770	QTERN	dapagliflozin and saxagliptin
0310-6780	QTERN	dapagliflozin and saxagliptin