Synjardy

Product NDC: 0597-0159
Requested package NDC: 0597-0159-66
11-digit product format: 005970159
Labeler code: 0597
Product ID: 0597-0159_06cb5e7a-ca7a-474a-a968-b3ddc7af1c43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: empagliflozin and metformin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA206111
Marketing category: NDA
Marketing start: 2015-08-26
Substance: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength: 5; 500 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#

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0597-0159	0597-0159-66	D	Discontinued by firm		2026-08-03

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 (package): 0597-0159-66 ndc (product): 0597-0159 ndc11 (package): 00597015966

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EMPAGLIFLOZIN	5 mg/1
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1664315	Internal RxNorm lookup
1664321	Internal RxNorm lookup
1664323	Internal RxNorm lookup
1664325	Internal RxNorm lookup
1664326	Internal RxNorm lookup
1664328	Internal RxNorm lookup
1665367	Internal RxNorm lookup
1665369	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
0fdd0255-0055-65f3-b2c0-db8fbb87beae	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
0597-0159-18	Synjardy	180 in 1 BOTTLE	TABLET	180	22
0597-0159-60	Synjardy	60 in 1 BOTTLE	TABLET	60	22
0597-0159-66	Synjardy	1 in 1 CARTON	TABLET	1	22
0597-0159-66	Synjardy	14 in 1 BOTTLE	TABLET	14	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0159-18	EA - Each	0597-0159	a4f5f719-1233-44d2-8356-29051f08bfd0	1	2015-10-02
0597-0159-60	EA - Each	0597-0159	c6a8da1d-5e57-45f3-a641-4ed42f47f29e	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EMPAGLIFLOZIN	ACTIVE INGREDIENT	HDC1R2M35U	SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
EMPAGLIFLOZIN	ACTIVE MOIETY	HDC1R2M35U	SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0159	SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	20	Current NDC, Legacy NDC, 4 package rows	20250327_0fdd0255-0055-65f3-b2c0-db8fbb87beae.zip

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
1665367	empagliflozin 12.5 MG / metFORMIN HCl 1000 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664323	empagliflozin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664326	empagliflozin 5 MG / metFORMIN HCl 1000 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664315	empagliflozin 5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1665369	Synjardy 12.5 MG / 1000 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664325	Synjardy 12.5 MG / 500 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664328	Synjardy 5 MG / 1000 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664321	Synjardy 5 MG / 500 MG Oral Tablet	PSN	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1665369	empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]	SBD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664325	empagliflozin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet [Synjardy]	SBD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664328	empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]	SBD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664321	empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet [Synjardy]	SBD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1665367	empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet	SCD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664323	empagliflozin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664326	empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet	SCD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664315	empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1665369	Synjardy (empagliflozin 12.5 MG / metformin hydrochloride 1000 MG) Oral Tablet	SY	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664325	Synjardy (empagliflozin 12.5 MG / metformin hydrochloride 500 MG) Oral Tablet	SY	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664328	Synjardy (empagliflozin 5 MG / metformin hydrochloride 1000 MG) Oral Tablet	SY	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22
1664321	Synjardy (empagliflozin 5 MG / metformin hydrochloride 500 MG) Oral Tablet	SY	0fdd0255-0055-65f3-b2c0-db8fbb87beae	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0159-66	00597015966	1 BOTTLE in 1 CARTON (0597-0159-66) > 14 TABLET in 1 BOTTLE	1 bottle	2015-09-12	0000-00-00	No	No	Current