QTERNMET

Product NDC
0310-6990
11-digit product format
003106990
Labeler code
0310
Product ID
0310-6990_19500f2f-6cc0-4c18-ad84-e33206608c10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapagliflozin saxagliptin and metformin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA210874
Marketing category
NDA
Marketing start
2020-06-01
Marketing end
0000-00-00
Substance
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active strength
10 mg/1; mg/1; mg/1
Pharmacologic 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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-6990-300031069903030 TABLET, FILM COATED in 1 BOTTLE (0310-6990-30) 2020-06-010000-00-00NoNoCurrent