Application 206111

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;500MG	Yes	No
002	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;1GM	Yes	No
003	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	12.5MG;500MG	Yes	No
004	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	12.5MG;1GM	Yes	Yes

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
N206111-001	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	RLD	2015-08-26
N206111-002	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	RLD	2015-08-26
N206111-003	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26
N206111-004	SYNJARDY	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206111-001	7713938	2027-04-15		Drug substance, Drug product	2015-09-30
N206111-001	7713938*PED	2027-10-15		Pediatric extension
N206111-001	7579449	2028-08-01		Drug substance	2015-09-30
N206111-001	7579449*PED	2029-02-01		Pediatric extension
N206111-001	12115179	2030-02-11	U-4023		2024-11-12
N206111-001	12115179*PED	2030-08-11		Pediatric extension
N206111-001	10610489	2030-09-30		Drug product	2020-05-01
N206111-001	10610489*PED	2031-03-30		Pediatric extension
N206111-001	12527810	2033-04-22	U-4403		2026-02-10
N206111-001	12527810*PED	2033-10-22		Pediatric extension
N206111-001	10258637	2034-04-03	U-2290		2019-04-30
N206111-001	11090323	2034-04-03	U-3193		2021-08-20
N206111-001	11666590	2034-04-03	U-4154		2025-03-28
N206111-001	11813275	2034-04-03	U-3759		2023-12-13
N206111-001	11833166	2034-04-03	U-3776		2024-01-03
N206111-001	11833166	2034-04-03	U-3777		2024-01-03
N206111-001	12263153	2034-04-03	U-4154		2025-04-29
N206111-001	12427162	2034-04-03	U-4287		2025-10-29
N206111-001	12433906	2034-04-03	U-4293		2025-10-29
N206111-001	12433906	2034-04-03	U-4294		2025-10-29
N206111-001	12433906	2034-04-03	U-4295		2025-10-29
N206111-001	12433906	2034-04-03	U-4296		2025-10-29
N206111-001	12433906	2034-04-03	U-4304		2025-10-29
N206111-001	9949997	2034-05-17	U-3532		2023-03-01
N206111-001	9949997	2034-05-17	U-3533		2023-03-01
N206111-001	10258637*PED	2034-10-03		Pediatric extension
N206111-001	11090323*PED	2034-10-03		Pediatric extension
N206111-001	11813275*PED	2034-10-03		Pediatric extension
N206111-001	11833166*PED	2034-10-03		Pediatric extension
N206111-001	12433906*PED	2034-10-03		Pediatric extension
N206111-001	9949997*PED	2034-11-17		Pediatric extension
N206111-002	7713938	2027-04-15		Drug substance, Drug product	2015-09-30
N206111-002	7713938*PED	2027-10-15		Pediatric extension
N206111-002	7579449	2028-08-01		Drug substance	2015-09-30
N206111-002	7579449*PED	2029-02-01		Pediatric extension
N206111-002	12115179	2030-02-11	U-4023		2024-11-12
N206111-002	12115179*PED	2030-08-11		Pediatric extension
N206111-002	10610489	2030-09-30		Drug product	2020-05-01
N206111-002	10610489*PED	2031-03-30		Pediatric extension
N206111-002	12527810	2033-04-22	U-4403		2026-02-10
N206111-002	12527810*PED	2033-10-22		Pediatric extension
N206111-002	10258637	2034-04-03	U-2290		2019-04-30
N206111-002	11090323	2034-04-03	U-3193		2021-08-20
N206111-002	11666590	2034-04-03	U-4154		2025-03-28
N206111-002	11813275	2034-04-03	U-3759		2023-12-13
N206111-002	11833166	2034-04-03	U-3776		2024-01-03
N206111-002	11833166	2034-04-03	U-3777		2024-01-03
N206111-002	12263153	2034-04-03	U-4154		2025-04-29
N206111-002	12427162	2034-04-03	U-4287		2025-10-29
N206111-002	12433906	2034-04-03	U-4293		2025-10-29
N206111-002	12433906	2034-04-03	U-4294		2025-10-29
N206111-002	12433906	2034-04-03	U-4295		2025-10-29
N206111-002	12433906	2034-04-03	U-4296		2025-10-29
N206111-002	12433906	2034-04-03	U-4304		2025-10-29
N206111-002	9949997	2034-05-17	U-3532		2023-03-01
N206111-002	9949997	2034-05-17	U-3533		2023-03-01
N206111-002	10258637*PED	2034-10-03		Pediatric extension
N206111-002	11090323*PED	2034-10-03		Pediatric extension
N206111-002	11813275*PED	2034-10-03		Pediatric extension
N206111-002	11833166*PED	2034-10-03		Pediatric extension
N206111-002	12433906*PED	2034-10-03		Pediatric extension
N206111-002	9949997*PED	2034-11-17		Pediatric extension
N206111-003	7713938	2027-04-15		Drug substance, Drug product	2015-09-30
N206111-003	7713938*PED	2027-10-15		Pediatric extension
N206111-003	7579449	2028-08-01		Drug substance	2015-09-30
N206111-003	7579449*PED	2029-02-01		Pediatric extension
N206111-003	12115179	2030-02-11	U-4023		2024-11-12
N206111-003	12115179*PED	2030-08-11		Pediatric extension
N206111-003	10610489	2030-09-30		Drug product	2020-05-01
N206111-003	10610489*PED	2031-03-30		Pediatric extension
N206111-003	12527810	2033-04-22	U-4403		2026-02-10
N206111-003	12527810*PED	2033-10-22		Pediatric extension
N206111-003	10258637	2034-04-03	U-2290		2019-04-30
N206111-003	11090323	2034-04-03	U-3193		2021-08-20
N206111-003	11666590	2034-04-03	U-4154		2025-03-28
N206111-003	11833166	2034-04-03	U-3776		2024-01-03
N206111-003	11833166	2034-04-03	U-3777		2024-01-03
N206111-003	12263153	2034-04-03	U-4154		2025-04-29
N206111-003	12427162	2034-04-03	U-4287		2025-10-29
N206111-003	12433906	2034-04-03	U-4293		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
N206111-001	NPP	2026-06-20
N206111-001	PED	2026-12-20
N206111-002	NPP	2026-06-20
N206111-002	PED	2026-12-20
N206111-003	NPP	2026-06-20
N206111-003	PED	2026-12-20
N206111-004	NPP	2026-06-20
N206111-004	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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206111-001	SYNJARDY	5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206111-002	SYNJARDY	5MG;1GM	TABLET / ORAL	RLD	2015-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206111-003	SYNJARDY	12.5MG;500MG	TABLET / ORAL	RLD	2015-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206111-004	SYNJARDY	12.5MG;1GM	TABLET / ORAL	RLD, RS	2015-08-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206111-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206111-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N206111-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N206111-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N206111-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206111-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N206111-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N206111-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N206111-004	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 46 · 1,816 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206111-001	7713938	2027-04-15		Drug substance, Drug product	2015-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	7713938*PED	2027-10-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	7579449	2028-08-01		Drug substance	2015-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	7579449*PED	2029-02-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12115179	2030-02-11	U-4023		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12115179*PED	2030-08-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	10610489	2030-09-30		Drug product	2020-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	10610489*PED	2031-03-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	10258637	2034-04-03	U-2290		2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11090323	2034-04-03	U-3193		2021-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11666590	2034-04-03	U-4154		2025-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11813275	2034-04-03	U-3759		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11833166	2034-04-03	U-3776		2024-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11833166	2034-04-03	U-3777		2024-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12263153	2034-04-03	U-4154		2025-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12427162	2034-04-03	U-4287		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12433906	2034-04-03	U-4304		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12433906	2034-04-03	U-4293		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12433906	2034-04-03	U-4294		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12433906	2034-04-03	U-4295		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12433906	2034-04-03	U-4296		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	9949997	2034-05-17	U-3532		2023-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	9949997	2034-05-17	U-3533		2023-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	10258637*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11090323*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11813275*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	11833166*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	12433906*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	9949997*PED	2034-11-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	7713938	2027-04-15		Drug substance, Drug product	2015-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	7713938*PED	2027-10-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	7579449	2028-08-01		Drug substance	2015-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	7579449*PED	2029-02-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	12115179	2030-02-11	U-4023		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	12115179*PED	2030-08-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	10610489	2030-09-30		Drug product	2020-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	10610489*PED	2031-03-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	10258637	2034-04-03	U-2290		2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	11090323	2034-04-03	U-3193		2021-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	11666590	2034-04-03	U-4154		2025-03-28	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 208 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206111-001	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-002	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-003	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-003	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-004	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206111-004	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-001	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-002	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-002	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-003	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-003	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-004	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206111-004	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206111-001	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-002	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-002	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-003	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-003	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-004	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206111-004	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-001	NPP	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-001	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-002	NPP	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-002	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-003	NPP	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-003	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-004	NPP	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206111-004	PED	2026-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-001	NPP	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-001	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-002	NPP	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-002	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-003	NPP	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-003	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-004	NPP	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206111-004	PED	2026-12-20	`b8a1b40f171c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	0fdd0255-0055-65f3-b2c0-db8fbb87beae	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206111 application number: NDA206111 ndc (product): 0597-0180 ndc (product): 0597-0168 ndc (product): 0597-0159 ndc (product): 0597-0175

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0159	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0159	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0159	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0159	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0159	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0168	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0168	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0168	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0168	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0168	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0175	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0175	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0175	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0175	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0175	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0180	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0180	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0180	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0180	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0180	Synjardy	empagliflozin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83952	SUPPL	2025-10-28
83927	SUPPL	2025-10-27
83925	SUPPL	2025-10-27
81526	SUPPL	2025-03-11
81510	SUPPL	2025-03-11
76012	SUPPL	2023-10-31
75999	SUPPL	2023-10-31
74593	SUPPL	2023-06-22
74590	SUPPL	2023-06-22
74576	SUPPL	2023-06-21
73453	SUPPL	2023-02-10
73396	SUPPL	2023-02-07
72376	SUPPL	2022-10-17
72375	SUPPL	2022-10-17
72339	SUPPL	2022-10-14
70633	SUPPL	2022-03-28
70632	SUPPL	2022-03-28
70582	SUPPL	2022-03-22
67804	SUPPL	2021-06-15
67803	SUPPL	2021-06-15
67796	SUPPL	2021-06-14
67795	SUPPL	2021-06-14
67794	SUPPL	2021-06-14
61674	SUPPL	2020-01-27
61662	SUPPL	2020-01-27
56177	SUPPL	2018-10-30
56162	SUPPL	2018-10-29
56161	SUPPL	2018-10-29
50713	SUPPL	2017-12-15
50691	SUPPL	2017-12-14
50688	SUPPL	2017-12-14
46665	SUPPL	2017-01-04
46664	SUPPL	2017-01-04
46663	SUPPL	2017-01-04
46558	SUPPL	2016-12-27
46545	SUPPL	2016-12-27
45357	SUPPL	2016-09-22
45356	SUPPL	2016-09-22
46077	ORIG	2016-08-04
32780	SUPPL	2016-07-12
40525	SUPPL	2015-12-08
32781	SUPPL	2015-12-07
40524	ORIG	2015-09-02
32779	ORIG	2015-09-02