NDC 0310-6975

QTERNMET XR

Dapagliflozin Saxagliptin And Metformin Hydrochloride

QTERNMET XR 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; Metformin Hydrochloride.

• Product ID: 0310-6975_19500f2f-6cc0-4c18-ad84-e33206608c10
• NDC: 0310-6975
• Product Type: Human Prescription Drug
• Proprietary Name: QTERNMET XR
• Generic Name: Dapagliflozin Saxagliptin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA210874
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; 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],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0310-6975-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-6975-30)

• Marketing Start Date: 2020-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6975-30 [00310697530]

QTERNMET XR TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210874
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-06-01

Drug Details

NDC Crossover Matching brand name "QTERNMET XR" or generic name "Dapagliflozin Saxagliptin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0310-6925	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride
0310-6950	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride
0310-6975	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride
0310-6990	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride