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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0310-6990		D	Discontinued by firm		2026-07-31
excluded package	package	0310-6990	0310-6990-30	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210874-001	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02
N210874-002	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02
N210874-003	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02
N210874-004	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210874-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-001	6515117*PED	2026-04-04		Pediatric extension
N210874-001	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-001	8501698*PED	2027-12-20		Pediatric extension
N210874-001	8716251	2028-03-21		Drug product	2019-05-24
N210874-001	8716251*PED	2028-09-21		Pediatric extension
N210874-001	7919598	2029-12-16		Drug substance	2019-05-24
N210874-001	7919598*PED	2030-06-16		Pediatric extension
N210874-001	9616028	2030-11-12		Drug product	2019-05-24
N210874-001	9616028*PED	2031-05-12		Pediatric extension
N210874-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-002	6515117*PED	2026-04-04		Pediatric extension
N210874-002	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-002	8501698*PED	2027-12-20		Pediatric extension
N210874-002	8716251	2028-03-21		Drug product	2019-05-24
N210874-002	8716251*PED	2028-09-21		Pediatric extension
N210874-002	7919598	2029-12-16		Drug substance	2019-05-24
N210874-002	7919598*PED	2030-06-16		Pediatric extension
N210874-002	9616028	2030-11-12		Drug product	2019-05-24
N210874-002	9616028*PED	2031-05-12		Pediatric extension
N210874-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-003	6515117*PED	2026-04-04		Pediatric extension
N210874-003	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-003	8501698*PED	2027-12-20		Pediatric extension
N210874-003	8716251	2028-03-21		Drug product	2019-05-24
N210874-003	8716251*PED	2028-09-21		Pediatric extension
N210874-003	7919598	2029-12-16		Drug substance	2019-05-24
N210874-003	7919598*PED	2030-06-16		Pediatric extension
N210874-003	9616028	2030-11-12		Drug product	2019-05-24
N210874-003	9616028*PED	2031-05-12		Pediatric extension
N210874-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-004	6515117*PED	2026-04-04		Pediatric extension
N210874-004	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-004	8501698*PED	2027-12-20		Pediatric extension
N210874-004	8716251	2028-03-21		Drug product	2019-05-24
N210874-004	8716251*PED	2028-09-21		Pediatric extension
N210874-004	7919598	2029-12-16		Drug substance	2019-05-24
N210874-004	7919598*PED	2030-06-16		Pediatric extension
N210874-004	9616028	2030-11-12		Drug product	2019-05-24
N210874-004	9616028*PED	2031-05-12		Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210874-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1ULL0QJ8UC	DAPAGLIFLOZIN	461432-26-8	DAPAGLIFLOZIN
Z8J84YIX6L	SAXAGLIPTIN HYDROCHLORIDE	709031-78-7	SAXAGLIPTIN HYDROCHLORIDE
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-6990-30	00310699030	30 TABLET, FILM COATED in 1 BOTTLE (0310-6990-30)	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QTERNMET XR	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	3