Application 204629

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JARDIANCE	EMPAGLIFLOZIN	TABLET;ORAL	10MG	Yes	No
002	JARDIANCE	EMPAGLIFLOZIN	TABLET;ORAL	25MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204629-001	JARDIANCE	EMPAGLIFLOZIN	10MG	TABLET / ORAL		RLD	2014-08-01
N204629-002	JARDIANCE	EMPAGLIFLOZIN	25MG	TABLET / ORAL		RLD, RS	2014-08-01

Orange Book patents#

Current patent rows page 1 of 1 · 64 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204629-001	7713938	2027-04-15		Drug substance, Drug product	2014-08-15
N204629-001	7713938*PED	2027-10-15		Pediatric extension
N204629-001	7579449	2028-08-01		Drug substance	2014-08-15
N204629-001	7579449*PED	2029-02-01		Pediatric extension
N204629-001	8551957	2029-10-14	U-1651		2016-03-14
N204629-001	12115179	2030-02-11	U-4023		2024-11-12
N204629-001	8551957*PED	2030-04-14		Pediatric extension
N204629-001	12115179*PED	2030-08-11		Pediatric extension
N204629-001	12527810	2033-04-22	U-4403		2026-02-10
N204629-001	12527810*PED	2033-10-22		Pediatric extension
N204629-001	10258637	2034-04-03	U-2290		2019-04-30
N204629-001	11090323	2034-04-03	U-3191		2021-08-20
N204629-001	11666590	2034-04-03	U-3691		2023-10-03
N204629-001	11813275	2034-04-03	U-3759		2023-12-13
N204629-001	11813275	2034-04-03	U-3760		2023-12-13
N204629-001	11833166	2034-04-03	U-3776		2024-01-03
N204629-001	11833166	2034-04-03	U-3777		2024-01-03
N204629-001	12263153	2034-04-03	U-4171		2025-04-29
N204629-001	12427162	2034-04-03	U-4287		2025-10-17
N204629-001	12433906	2034-04-03	U-4293		2025-10-30
N204629-001	12433906	2034-04-03	U-4294		2025-10-30
N204629-001	12433906	2034-04-03	U-4295		2025-10-30
N204629-001	12433906	2034-04-03	U-4296		2025-10-30
N204629-001	12433906	2034-04-03	U-4304		2025-10-30
N204629-001	9949997	2034-05-17	U-2292		2018-05-15
N204629-001	9949997	2034-05-17	U-3199		2018-05-15
N204629-001	9949997	2034-05-17	U-3325		2018-05-15
N204629-001	9949998	2034-06-11	U-2290		2018-05-15
N204629-001	10258637*PED	2034-10-03		Pediatric extension
N204629-001	11090323*PED	2034-10-03		Pediatric extension
N204629-001	11813275*PED	2034-10-03		Pediatric extension
N204629-001	11833166*PED	2034-10-03		Pediatric extension
N204629-001	12433906*PED	2034-10-03		Pediatric extension
N204629-001	9949997*PED	2034-11-17		Pediatric extension
N204629-001	9949998*PED	2034-12-11		Pediatric extension
N204629-002	7713938	2027-04-15		Drug substance, Drug product	2014-08-15
N204629-002	7713938*PED	2027-10-15		Pediatric extension
N204629-002	7579449	2028-08-01		Drug substance	2014-08-15
N204629-002	7579449*PED	2029-02-01		Pediatric extension
N204629-002	8551957	2029-10-14	U-1651		2016-03-14
N204629-002	12115179	2030-02-11	U-4023		2024-11-12
N204629-002	8551957*PED	2030-04-14		Pediatric extension
N204629-002	12115179*PED	2030-08-11		Pediatric extension
N204629-002	12527810	2033-04-22	U-4403		2026-02-10
N204629-002	12527810*PED	2033-10-22		Pediatric extension
N204629-002	10258637	2034-04-03	U-2290		2019-04-30
N204629-002	11090323	2034-04-03	U-3191		2021-08-20
N204629-002	11833166	2034-04-03	U-3776		2024-01-03
N204629-002	11833166	2034-04-03	U-3777		2024-01-03
N204629-002	12263153	2034-04-03	U-4171		2025-04-29
N204629-002	12427162	2034-04-03	U-4287		2025-10-17
N204629-002	12433906	2034-04-03	U-4293		2025-10-30
N204629-002	12433906	2034-04-03	U-4294		2025-10-30
N204629-002	12433906	2034-04-03	U-4295		2025-10-30
N204629-002	12433906	2034-04-03	U-4296		2025-10-30
N204629-002	12433906	2034-04-03	U-4304		2025-10-30
N204629-002	9949997	2034-05-17	U-2292		2018-05-15
N204629-002	9949998	2034-06-11	U-2290		2018-05-15
N204629-002	10258637*PED	2034-10-03		Pediatric extension
N204629-002	11090323*PED	2034-10-03		Pediatric extension
N204629-002	11833166*PED	2034-10-03		Pediatric extension
N204629-002	12433906*PED	2034-10-03		Pediatric extension
N204629-002	9949997*PED	2034-11-17		Pediatric extension
N204629-002	9949998*PED	2034-12-11		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204629-001	NPP	2026-06-20
N204629-001	I-922	2026-09-21
N204629-001	PED	2026-12-20
N204629-002	NPP	2026-06-20
N204629-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	N204629-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204629-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204629-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204629-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204629-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204629-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204629-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N204629-002	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,192 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204629-001	7713938	2027-04-15		Drug substance, Drug product	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	7713938*PED	2027-10-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	7579449	2028-08-01		Drug substance	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	7579449*PED	2029-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	8551957	2029-10-14	U-1651		2016-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12115179	2030-02-11	U-4023		2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	8551957*PED	2030-04-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12115179*PED	2030-08-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12527810	2033-04-22	U-4403		2026-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12527810*PED	2033-10-22		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	10258637	2034-04-03	U-2290		2019-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11090323	2034-04-03	U-3191		2021-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11666590	2034-04-03	U-3691		2023-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11813275	2034-04-03	U-3759		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11813275	2034-04-03	U-3760		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11833166	2034-04-03	U-3776		2024-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11833166	2034-04-03	U-3777		2024-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12263153	2034-04-03	U-4171		2025-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12427162	2034-04-03	U-4287		2025-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12433906	2034-04-03	U-4304		2025-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12433906	2034-04-03	U-4293		2025-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12433906	2034-04-03	U-4294		2025-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12433906	2034-04-03	U-4295		2025-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12433906	2034-04-03	U-4296		2025-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	9949997	2034-05-17	U-2292		2018-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	9949997	2034-05-17	U-3325		2018-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	9949997	2034-05-17	U-3199		2018-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	9949998	2034-06-11	U-2290		2018-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	10258637*PED	2034-10-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11090323*PED	2034-10-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11813275*PED	2034-10-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	11833166*PED	2034-10-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	12433906*PED	2034-10-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	9949997*PED	2034-11-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	9949998*PED	2034-12-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	7713938	2027-04-15		Drug substance, Drug product	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	7713938*PED	2027-10-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	7579449	2028-08-01		Drug substance	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	7579449*PED	2029-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	8551957	2029-10-14	U-1651		2016-03-14	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 203 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N204629-001	NPP	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	I-922	2026-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-001	PED	2026-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	NPP	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204629-002	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204629-001	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204629-001	I-922	2026-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204629-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204629-002	NPP	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204629-002	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-001	M-82	2025-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-001	PED	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-001	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-001	I-922	2026-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-002	NPP	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204629-002	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204629-001	M-82	2025-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-001	PED	2025-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-001	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-001	I-922	2026-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-002	NPP	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204629-002	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-001	M-82	2025-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-001	PED	2025-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-001	NPP	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-001	I-922	2026-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-001	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-002	NPP	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204629-002	PED	2026-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-001	M-82	2025-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-001	PED	2025-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-001	NPP	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-001	I-922	2026-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-001	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-002	NPP	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204629-002	PED	2026-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204629-001	I-869	2024-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204629-001	M-82	2025-02-24	`03ed91905a0d…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jardiance	EMPAGLIFLOZIN	Redpharm Drug	59ed43d9-b4e0-72a2-e063-6394a90a327d	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629
Jardiance	EMPAGLIFLOZIN	Aphena Pharma Solutions - Tennessee, LLC	334f1b3d-5670-6685-e063-6294a90a7e47	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629
Jardiance	EMPAGLIFLOZIN	Cardinal Health 107, LLC	5777b8a8-ada6-4950-8548-43a1de11f075	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629 ndc (product): 55154-0411 ndc (product): 55154-0412
Jardiance	EMPAGLIFLOZIN	Boehringer Ingelheim Pharmaceuticals, Inc.	faf3dd6a-9cd0-39c2-0d2e-232cb3f67565	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629 ndc (product): 0597-0152 ndc (product): 0597-0153
Jardiance	EMPAGLIFLOZIN	Aphena Pharma Solutions - Tennessee, LLC	8b6261f6-4bdc-462e-8af1-4064664c62f3	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629 ndc (product): 71610-177
Jardiance	EMPAGLIFLOZIN	A-S Medication Solutions	a77214ca-572e-485e-aae9-f7950187e5fb	2023-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629 ndc (product): 50090-4384
JARDIANCE	EMPAGLIFLOZIN	A-S Medication Solutions	942a82a4-cbbd-4e44-9965-8d03f767912b	2023-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629 ndc (product): 50090-4492
JARDIANCE	EMPAGLIFLOZIN	A-S Medication Solutions	1782b947-4a72-4feb-a488-1469d9af82bd	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629
JARDIANCE	EMPAGLIFLOZIN	A-S Medication Solutions	f2b41c77-0abb-40ee-8578-86a748d0e19e	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204629 application number: NDA204629

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0152	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0153	Jardiance	Empagliflozin	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4384	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4492	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4492	JARDIANCE	Empagliflozin	A-S Medication Solutions	NDA	Current
50090-4492	Jardiance	Empagliflozin	A-S Medication Solutions	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health 107, LLC	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0411	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health 107, LLC	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
55154-0412	Jardiance	Empagliflozin	Cardinal Health	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-1986	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
70518-2447	Jardiance	Empagliflozin	REMEDYREPACK INC.	NDA	Current
71610-177	Jardiance	Empagliflozin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-177	Jardiance	Empagliflozin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83951	SUPPL	2025-10-28
83924	SUPPL	2025-10-27
83923	SUPPL	2025-10-27
75559	SUPPL	2023-09-25
75532	SUPPL	2023-09-22
75438	SUPPL	2023-09-13
75414	SUPPL	2023-09-13
74588	SUPPL	2023-06-22
74575	SUPPL	2023-06-21
73523	SUPPL	2023-02-16
72380	SUPPL	2022-10-17
72379	SUPPL	2022-10-17
72337	SUPPL	2022-10-14
70618	SUPPL	2022-03-28
70617	SUPPL	2022-03-28
70580	SUPPL	2022-03-22
70277	SUPPL	2022-02-28
70276	SUPPL	2022-02-28
70270	SUPPL	2022-02-28
68418	SUPPL	2021-08-19
68417	SUPPL	2021-08-19
68411	SUPPL	2021-08-19
67800	SUPPL	2021-06-15
67799	SUPPL	2021-06-15
67782	SUPPL	2021-06-14
67781	SUPPL	2021-06-14
67780	SUPPL	2021-06-14
65830	SUPPL	2021-01-06
65829	SUPPL	2021-01-06
64668	SUPPL	2020-09-24
64667	SUPPL	2020-09-24
64666	SUPPL	2020-09-24
64011	SUPPL	2020-07-22
61672	SUPPL	2020-01-27
61664	SUPPL	2020-01-27
61663	SUPPL	2020-01-27
57065	SUPPL	2018-12-30
57018	SUPPL	2018-12-26
57017	SUPPL	2018-12-26
56175	SUPPL	2018-10-30
56158	SUPPL	2018-10-29
56157	SUPPL	2018-10-29
50715	SUPPL	2017-12-15
50692	SUPPL	2017-12-14
46031	SUPPL	2016-12-06
46011	SUPPL	2016-12-05
10369	SUPPL	2016-07-12
19580	SUPPL	2016-03-22
10368	SUPPL	2016-03-22
19579	SUPPL	2016-03-04
32575	SUPPL	2016-02-09
32576	SUPPL	2015-12-08
19581	SUPPL	2015-12-08
40402	SUPPL	2015-07-01
40401	SUPPL	2015-07-01
19578	SUPPL	2015-07-01
32574	SUPPL	2015-06-30
32573	SUPPL	2015-06-30
10367	SUPPL	2015-06-30
43470	ORIG	2014-09-09
24474	ORIG	2014-09-09
32572	ORIG	2014-08-04
19577	ORIG	2014-08-04