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 ID: 0310-6770_49e0634f-e72d-4c07-8336-d197048e78ba
• NDC: 0310-6770
• 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: 5 mg/1; mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0310-6770-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)

• Marketing Start Date: 2019-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6770-30 [00310677030]

QTERN TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209091
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-17

NDC 0310-6770-95 [00310677095]

QTERN TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209091
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

Drug Details

Active Ingredients

Ingredient	Strength
DAPAGLIFLOZIN	5 mg/1

OpenFDA Data

• SPL SET ID: 423c489c-085b-4320-b892-7868ebd6dc6b
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • Z8J84YIX6L
  • 1ULL0QJ8UC
• 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"

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