Application 212614

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG;1GM	Yes	No
002	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;5MG;1GM	Yes	No
003	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;2.5MG;1GM	Yes	No
004	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	25MG;5MG;1GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N212614-001	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27
N212614-002	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27
N212614-003	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27
N212614-004	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27

Orange Book patents#

Current patent rows page 1 of 2 · 119 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212614-001	8883805	2025-11-26		Drug product	2020-02-18
N212614-001	8883805*PED	2026-05-26		Pediatric extension
N212614-001	7713938	2027-04-15		Drug substance, Drug product	2020-02-18
N212614-001	7713938*PED	2027-10-15		Pediatric extension
N212614-001	7579449	2028-08-01		Drug substance	2020-02-18
N212614-001	7579449*PED	2029-02-01		Pediatric extension
N212614-001	10022379	2029-04-02	U-2732	Drug product	2020-02-18
N212614-001	12678442	2029-04-02		Drug product	2026-08-07
N212614-001	9415016	2029-04-02		Drug product	2020-02-18
N212614-001	12678442*PED	2029-10-02		Pediatric extension
N212614-001	8551957	2029-10-14	U-2730	Drug product	2020-02-18
N212614-001	12115179	2030-02-11	U-4023		2024-11-12
N212614-001	8551957*PED	2030-04-14		Pediatric extension
N212614-001	9155705	2030-05-21		Drug product	2020-02-18
N212614-001	10406172	2030-06-15	U-2733	Drug product	2020-02-18
N212614-001	12115179*PED	2030-08-11		Pediatric extension
N212614-001	10596120	2032-03-07	U-2776	Drug product	2020-04-21
N212614-001	10596120	2032-03-07	U-2790	Drug product	2020-04-21
N212614-001	11564886	2032-03-07	U-3531	Drug product	2023-03-01
N212614-001	10258637	2034-04-03	U-2731		2020-02-18
N212614-001	11090323	2034-04-03	U-3192		2021-08-20
N212614-001	11833166	2034-04-03	U-3776		2024-01-03
N212614-001	11833166	2034-04-03	U-3777		2024-01-03
N212614-001	9949998	2034-06-11	U-2731		2020-02-18
N212614-001	10258637*PED	2034-10-03		Pediatric extension
N212614-001	11090323*PED	2034-10-03		Pediatric extension
N212614-001	11833166*PED	2034-10-03		Pediatric extension
N212614-001	9949998*PED	2034-12-11		Pediatric extension
N212614-001	12364700	2037-06-08	U-4224		2025-07-31
N212614-001	12364700*PED	2037-12-08		Pediatric extension
N212614-002	8883805	2025-11-26		Drug product	2020-02-18
N212614-002	8883805*PED	2026-05-26		Pediatric extension
N212614-002	7713938	2027-04-15		Drug substance, Drug product	2020-02-18
N212614-002	7713938*PED	2027-10-15		Pediatric extension
N212614-002	7579449	2028-08-01		Drug substance	2020-02-18
N212614-002	7579449*PED	2029-02-01		Pediatric extension
N212614-002	10022379	2029-04-02	U-2732	Drug product	2020-02-18
N212614-002	12678442	2029-04-02		Drug product	2026-08-07
N212614-002	9415016	2029-04-02		Drug product	2020-02-18
N212614-002	12678442*PED	2029-10-02		Pediatric extension
N212614-002	8551957	2029-10-14	U-2730	Drug product	2020-02-18
N212614-002	12115179	2030-02-11	U-4023		2024-11-12
N212614-002	8551957*PED	2030-04-14		Pediatric extension
N212614-002	9155705	2030-05-21		Drug product	2020-02-18
N212614-002	10406172	2030-06-15	U-2733	Drug product	2020-02-18
N212614-002	12115179*PED	2030-08-11		Pediatric extension
N212614-002	10596120	2032-03-07	U-2776	Drug product	2020-04-21
N212614-002	10596120	2032-03-07	U-2790	Drug product	2020-04-21
N212614-002	11564886	2032-03-07	U-3531	Drug product	2023-03-01
N212614-002	10258637	2034-04-03	U-2731		2020-02-18
N212614-002	11090323	2034-04-03	U-3192		2021-08-20
N212614-002	11833166	2034-04-03	U-3776		2024-01-03
N212614-002	11833166	2034-04-03	U-3777		2024-01-03
N212614-002	9949998	2034-06-11	U-2731		2020-02-18
N212614-002	10258637*PED	2034-10-03		Pediatric extension
N212614-002	11090323*PED	2034-10-03		Pediatric extension
N212614-002	11833166*PED	2034-10-03		Pediatric extension
N212614-002	9949998*PED	2034-12-11		Pediatric extension
N212614-002	12364700	2037-06-08	U-4224		2025-07-31
N212614-002	12364700*PED	2037-12-08		Pediatric extension
N212614-003	8883805	2025-11-26		Drug product	2020-02-18
N212614-003	8883805*PED	2026-05-26		Pediatric extension
N212614-003	7713938	2027-04-15		Drug substance, Drug product	2020-02-18
N212614-003	7713938*PED	2027-10-15		Pediatric extension
N212614-003	7579449	2028-08-01		Drug substance	2020-02-18
N212614-003	7579449*PED	2029-02-01		Pediatric extension
N212614-003	10022379	2029-04-02	U-2732	Drug product	2020-02-18
N212614-003	12678442	2029-04-02		Drug product	2026-08-07
N212614-003	9415016	2029-04-02		Drug product	2020-02-18
N212614-003	12678442*PED	2029-10-02		Pediatric extension
N212614-003	8551957	2029-10-14	U-2730	Drug product	2020-02-18
N212614-003	12115179	2030-02-11	U-4023		2024-11-12
N212614-003	8551957*PED	2030-04-14		Pediatric extension
N212614-003	9155705	2030-05-21		Drug product	2020-02-18
N212614-003	10406172	2030-06-15	U-2733	Drug product	2020-02-18
N212614-003	12115179*PED	2030-08-11		Pediatric extension
N212614-003	10596120	2032-03-07	U-2776	Drug product	2020-04-21
N212614-003	10596120	2032-03-07	U-2790	Drug product	2020-04-21
N212614-003	11564886	2032-03-07	U-3531	Drug product	2023-03-01
N212614-003	10258637	2034-04-03	U-2731		2020-02-18

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 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212614-001	TRIJARDY XR	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212614-002	TRIJARDY XR	10MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212614-003	TRIJARDY XR	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2020-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212614-004	TRIJARDY XR	25MG;5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2020-01-27	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 85 · 3,371 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212614-001	8883805	2025-11-26		Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	8883805*PED	2026-05-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	7713938	2027-04-15		Drug substance, Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	7579449	2028-08-01		Drug substance	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	10022379	2029-04-02	U-2732	Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	12678442	2029-04-02		Drug product	2026-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	9415016	2029-04-02		Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	12678442*PED	2029-10-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	8551957	2029-10-14	U-2730	Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	12115179	2030-02-11	U-4023		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	8551957*PED	2030-04-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	9155705	2030-05-21		Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	10406172	2030-06-15	U-2733	Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	12115179*PED	2030-08-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	10596120	2032-03-07	U-2790	Drug product	2020-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	10596120	2032-03-07	U-2776	Drug product	2020-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	11564886	2032-03-07	U-3531	Drug product	2023-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	10258637	2034-04-03	U-2731		2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	11090323	2034-04-03	U-3192		2021-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	11833166	2034-04-03	U-3776		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	11833166	2034-04-03	U-3777		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	9949998	2034-06-11	U-2731		2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	10258637*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	11090323*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	11833166*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	9949998*PED	2034-12-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	12364700	2037-06-08	U-4224		2025-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-001	12364700*PED	2037-12-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	8883805	2025-11-26		Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	8883805*PED	2026-05-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	7713938	2027-04-15		Drug substance, Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	7579449	2028-08-01		Drug substance	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	10022379	2029-04-02	U-2732	Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	12678442	2029-04-02		Drug product	2026-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	9415016	2029-04-02		Drug product	2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212614-002	12678442*PED	2029-10-02		Pediatric extension		`84e616aacf4f…`

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
Trijardy XR	EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	71873567-9594-452a-bb92-34a129adecac	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212614 application number: NDA212614 ndc (product): 0597-0380 ndc (product): 0597-0390 ndc (product): 0597-0395 ndc (product): 0597-0385

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83955	SUPPL	2025-10-28
83935	SUPPL	2025-10-27
83934	SUPPL	2025-10-27
76014	SUPPL	2023-10-31
76003	SUPPL	2023-10-31
72486	SUPPL	2022-10-28
72485	SUPPL	2022-10-28
72326	SUPPL	2022-10-14
67806	SUPPL	2021-06-15
67805	SUPPL	2021-06-15
67785	SUPPL	2021-06-14
67784	SUPPL	2021-06-14
67783	SUPPL	2021-06-14
65143	SUPPL	2020-11-03
65142	SUPPL	2020-11-03
65133	SUPPL	2020-11-03
64830	ORIG	2020-10-05
61705	ORIG	2020-01-28
61703	ORIG	2020-01-28
61702	ORIG	2020-01-28