QTERNMET

Product NDC: 0310-6925
11-digit product format: 003106925
Labeler code: 0310
Product ID: 0310-6925_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: 3 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	0310-6925		D	Discontinued by firm		2026-08-17
excluded package	package	0310-6925	0310-6925-60	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-6925-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-6925-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-6925-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-6925-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-6925-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-6925-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-6925-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-6925-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-6925-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-6925-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-6925-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-6925-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210874-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	8501698	2027-06-20	U-493	Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	8716251	2028-03-21		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	7919598	2029-12-16		Drug substance	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	9616028	2030-11-12		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-001	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	8501698	2027-06-20	U-493	Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	8716251	2028-03-21		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	7919598	2029-12-16		Drug substance	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	9616028	2030-11-12		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-002	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	8501698	2027-06-20	U-493	Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	8716251	2028-03-21		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	7919598	2029-12-16		Drug substance	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	9616028	2030-11-12		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-003	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	8501698	2027-06-20	U-493	Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	8716251	2028-03-21		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	7919598	2029-12-16		Drug substance	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	9616028	2030-11-12		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210874-004	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-001	NP	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-002	NP	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-003	NP	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-004	NP	2022-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210874-001	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-002	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-003	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-004	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210874-001	NP	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-002	NP	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-003	NP	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-004	NP	2022-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210874-001	NP	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210874-002	NP	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210874-003	NP	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210874-004	NP	2022-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210874-001	NP	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210874-002	NP	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210874-003	NP	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210874-004	NP	2022-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210874-001	NP	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210874-002	NP	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210874-003	NP	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210874-004	NP	2022-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-001	NP	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-002	NP	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-003	NP	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-004	NP	2022-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210874-001	NP	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210874-002	NP	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210874-003	NP	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210874-004	NP	2022-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210874-001	NP	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210874-002	NP	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210874-003	NP	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210874-004	NP	2022-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210874-001	NP	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210874-002	NP	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210874-003	NP	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210874-004	NP	2022-05-02	`c0c555d07b60…`

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
0310-6925-60	00310692560	60 TABLET, FILM COATED in 1 BOTTLE (0310-6925-60)	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