Synjardy

Product NDC: 0597-0295
Requested package NDC: 0597-0295-78
11-digit product format: 005970295
Labeler code: 0597
Product ID: 0597-0295_92a5c89e-3862-4a40-aee0-9134938f9629
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: empagliflozin, metformin hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA208658
Marketing category: NDA
Marketing start: 2016-12-10
Substance: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength: 25; 1000 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0597-0295	0597-0295-78	D	Discontinued by firm		2026-10-30

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208658-001	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09
N208658-002	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09
N208658-003	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09
N208658-004	SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09

Orange Book patents#

Current patent rows page 1 of 2 · 124 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208658-001	7713938	2027-04-15		Drug substance, Drug product	2017-01-04
N208658-001	7713938*PED	2027-10-15		Pediatric extension
N208658-001	7579449	2028-08-01		Drug substance	2017-01-04
N208658-001	7579449*PED	2029-02-01		Pediatric extension
N208658-001	12115179	2030-02-11	U-4023		2024-11-12
N208658-001	12115179*PED	2030-08-11		Pediatric extension
N208658-001	10596120	2032-03-07	U-2775	Drug product	2020-04-20
N208658-001	10596120	2032-03-07	U-2792	Drug product	2020-04-20
N208658-001	10596120*PED	2032-09-07		Pediatric extension
N208658-001	10258637	2034-04-03	U-2290		2019-04-30
N208658-001	11090323	2034-04-03	U-3193		2021-08-20
N208658-001	11666590	2034-04-03	U-4154		2025-03-28
N208658-001	11813275	2034-04-03	U-3759		2023-12-13
N208658-001	11833166	2034-04-03	U-3776		2024-01-03
N208658-001	11833166	2034-04-03	U-3777		2024-01-03
N208658-001	12263153	2034-04-03	U-4154		2025-04-29
N208658-001	12427162	2034-04-03	U-4287		2025-10-29
N208658-001	12433906	2034-04-03	U-4293		2025-10-29
N208658-001	12433906	2034-04-03	U-4294		2025-10-29
N208658-001	12433906	2034-04-03	U-4295		2025-10-29
N208658-001	12433906	2034-04-03	U-4296		2025-10-29
N208658-001	12433906	2034-04-03	U-4304		2025-10-29
N208658-001	9949997	2034-05-17	U-3532		2023-03-01
N208658-001	9949997	2034-05-17	U-3533		2023-03-01
N208658-001	9949998	2034-06-11	U-2290		2018-05-16
N208658-001	10258637*PED	2034-10-03		Pediatric extension
N208658-001	11090323*PED	2034-10-03		Pediatric extension
N208658-001	11813275*PED	2034-10-03		Pediatric extension
N208658-001	11833166*PED	2034-10-03		Pediatric extension
N208658-001	12433906*PED	2034-10-03		Pediatric extension
N208658-001	9949997*PED	2034-11-17		Pediatric extension
N208658-001	9949998*PED	2034-12-11		Pediatric extension
N208658-002	7713938	2027-04-15		Drug substance, Drug product	2017-01-04
N208658-002	7713938*PED	2027-10-15		Pediatric extension
N208658-002	7579449	2028-08-01		Drug substance	2017-01-04
N208658-002	7579449*PED	2029-02-01		Pediatric extension
N208658-002	12115179	2030-02-11	U-4023		2024-11-12
N208658-002	12115179*PED	2030-08-11		Pediatric extension
N208658-002	10596120	2032-03-07	U-2775	Drug product	2020-04-20
N208658-002	10596120	2032-03-07	U-2792	Drug product	2020-04-20
N208658-002	10596120*PED	2032-09-07		Pediatric extension
N208658-002	10258637	2034-04-03	U-2290		2019-04-30
N208658-002	11090323	2034-04-03	U-3193		2021-08-20
N208658-002	11666590	2034-04-03	U-4154		2025-03-28
N208658-002	11813275	2034-04-03	U-3759		2023-12-13
N208658-002	11833166	2034-04-03	U-3776		2024-01-03
N208658-002	11833166	2034-04-03	U-3777		2024-01-03
N208658-002	12263153	2034-04-03	U-4154		2025-04-29
N208658-002	12427162	2034-04-03	U-4287		2025-10-29
N208658-002	12433906	2034-04-03	U-4293		2025-10-29
N208658-002	12433906	2034-04-03	U-4294		2025-10-29
N208658-002	12433906	2034-04-03	U-4295		2025-10-29
N208658-002	12433906	2034-04-03	U-4296		2025-10-29
N208658-002	12433906	2034-04-03	U-4304		2025-10-29
N208658-002	9949997	2034-05-17	U-3532		2023-03-01
N208658-002	9949997	2034-05-17	U-3533		2023-03-01
N208658-002	9949998	2034-06-11	U-2290		2018-05-16
N208658-002	10258637*PED	2034-10-03		Pediatric extension
N208658-002	11090323*PED	2034-10-03		Pediatric extension
N208658-002	11813275*PED	2034-10-03		Pediatric extension
N208658-002	11833166*PED	2034-10-03		Pediatric extension
N208658-002	12433906*PED	2034-10-03		Pediatric extension
N208658-002	9949997*PED	2034-11-17		Pediatric extension
N208658-002	9949998*PED	2034-12-11		Pediatric extension
N208658-003	7713938	2027-04-15		Drug substance, Drug product	2017-01-04
N208658-003	7713938*PED	2027-10-15		Pediatric extension
N208658-003	7579449	2028-08-01		Drug substance	2017-01-04
N208658-003	7579449*PED	2029-02-01		Pediatric extension
N208658-003	12115179	2030-02-11	U-4023		2024-11-12
N208658-003	12115179*PED	2030-08-11		Pediatric extension
N208658-003	10596120	2032-03-07	U-2775	Drug product	2020-04-20
N208658-003	10596120	2032-03-07	U-2792	Drug product	2020-04-20
N208658-003	10596120*PED	2032-09-07		Pediatric extension
N208658-003	10258637	2034-04-03	U-2290		2019-04-30
N208658-003	11090323	2034-04-03	U-3193		2021-08-20
N208658-003	11666590	2034-04-03	U-4154		2025-03-28
N208658-003	11833166	2034-04-03	U-3776		2024-01-03
N208658-003	11833166	2034-04-03	U-3777		2024-01-03
N208658-003	12263153	2034-04-03	U-4154		2025-04-29
N208658-003	12427162	2034-04-03	U-4287		2025-10-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208658-001	M-296	2026-06-20
N208658-001	PED	2026-12-20
N208658-002	M-296	2026-06-20
N208658-002	PED	2026-12-20
N208658-003	M-296	2026-06-20
N208658-003	PED	2026-12-20
N208658-004	M-296	2026-06-20
N208658-004	PED	2026-12-20

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-001	SYNJARDY XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-002	SYNJARDY XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-003	SYNJARDY XR	12.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208658-004	SYNJARDY XR	25MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-12-09	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 65 · 2,600 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208658-001	7713938	2027-04-15		Drug substance, Drug product	2017-01-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	7713938*PED	2027-10-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	7579449	2028-08-01		Drug substance	2017-01-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	7579449*PED	2029-02-01		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12115179	2030-02-11	U-4023		2024-11-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12115179*PED	2030-08-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	10596120	2032-03-07	U-2775	Drug product	2020-04-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	10596120	2032-03-07	U-2792	Drug product	2020-04-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	10596120*PED	2032-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	10258637	2034-04-03	U-2290		2019-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11090323	2034-04-03	U-3193		2021-08-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11666590	2034-04-03	U-4154		2025-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11813275	2034-04-03	U-3759		2023-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11833166	2034-04-03	U-3776		2024-01-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11833166	2034-04-03	U-3777		2024-01-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12263153	2034-04-03	U-4154		2025-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12427162	2034-04-03	U-4287		2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12433906	2034-04-03	U-4304		2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12433906	2034-04-03	U-4293		2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12433906	2034-04-03	U-4294		2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12433906	2034-04-03	U-4295		2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12433906	2034-04-03	U-4296		2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	9949997	2034-05-17	U-3532		2023-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	9949997	2034-05-17	U-3533		2023-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	9949998	2034-06-11	U-2290		2018-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	10258637*PED	2034-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11090323*PED	2034-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11813275*PED	2034-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	11833166*PED	2034-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	12433906*PED	2034-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	9949997*PED	2034-11-17		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	9949998*PED	2034-12-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	7713938	2027-04-15		Drug substance, Drug product	2017-01-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	7713938*PED	2027-10-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	7579449	2028-08-01		Drug substance	2017-01-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	7579449*PED	2029-02-01		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	12115179	2030-02-11	U-4023		2024-11-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	12115179*PED	2030-08-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	10596120	2032-03-07	U-2775	Drug product	2020-04-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	10596120	2032-03-07	U-2792	Drug product	2020-04-20	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N208658-001	M-296	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-001	PED	2026-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	M-296	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-002	PED	2026-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-003	M-296	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-003	PED	2026-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-004	M-296	2026-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208658-004	PED	2026-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208658-001	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-001	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-002	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-003	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-003	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-004	M-296	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208658-004	PED	2026-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208658-001	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-001	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-002	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-002	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-003	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-003	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-004	M-296	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208658-004	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208658-001	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-002	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-002	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-003	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-003	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-004	M-296	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208658-004	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-001	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-002	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-002	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-003	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-003	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-004	M-296	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208658-004	PED	2026-12-20	`31067a03dcf5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Synjardy
Brand name suffix: XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EMPAGLIFLOZIN	25 mg/1
METFORMIN HYDROCHLORIDE	1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup
HDC1R2M35U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1862685	Internal RxNorm lookup
1862688	Internal RxNorm lookup
1862691	Internal RxNorm lookup
1862692	Internal RxNorm lookup
1862695	Internal RxNorm lookup
1862697	Internal RxNorm lookup
1862700	Internal RxNorm lookup
1862701	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
a1e505bd-ab91-46e4-b7bc-a43a10199330	Product name	2	20170214
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
24acbc89-fd6a-458c-aa62-a3485b119bed	Product name	1	20150323
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0597-0295-61	SynjardyXR	7 in 1 BOTTLE	TABLET, EXTENDED RELEASE	7	17
0597-0295-61	SynjardyXR	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	17
0597-0295-78	SynjardyXR	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	17
0597-0295-88	SynjardyXR	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0295-78	EA - Each	0597-0295	2e0522c8-7577-464c-8983-28f8823ed6eb	1	2017-04-05
0597-0295-88	EA - Each	0597-0295	540e6e56-55de-4c9a-ada7-621302d77923	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0295	SYNJARDY XR (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 4 package rows	20250323_8006ba29-ee3a-f852-a9bb-c8ec9b41cf66.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Synjardy XR	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208658 application number: NDA208658 ndc (package): 0597-0295-78 ndc (product): 0597-0295 ndc11 (package): 00597029578

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDC1R2M35U	EMPAGLIFLOZIN	864070-44-0	EMPAGLIFLOZIN
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1862685	empagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862691	empagliflozin 12.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862695	empagliflozin 25 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862700	empagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862688	Synjardy XR 10 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862692	Synjardy XR 12.5 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862697	Synjardy XR 25 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862701	Synjardy XR 5 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862688	24 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]	SBD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862692	24 HR empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]	SBD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862697	24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]	SBD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862701	24 HR empagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]	SBD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862685	24 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862691	24 HR empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862695	24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862700	24 HR empagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862685	empagliflozin 10 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862691	empagliflozin 12.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862695	empagliflozin 25 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862700	empagliflozin 5 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862688	Synjardy XR 10 MG / 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862692	Synjardy XR 12.5 MG / 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862697	Synjardy XR 25 MG / 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17
1862701	Synjardy XR 5 MG / 1000 MG 24HR Extended Release Oral Tablet	SY	8006ba29-ee3a-f852-a9bb-c8ec9b41cf66	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0295-78	00597029578	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-78)	2016-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Synjardy XR	Boehringer Ingelheim Pharmaceuticals, Inc.	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	18