Jardiance

Product NDC: 67296-2324
Requested package NDC: 67296-2324-3
11-digit product format: 672962324
Labeler code: 67296
Product ID: 67296-2324_59ed43d9-b4e1-72a2-e063-6394a90a327d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Empagliflozin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Redpharm Drug
Application: NDA204629
Marketing category: NDA
Marketing start: 2014-08-01
Substance: EMPAGLIFLOZIN
Active strength: 25 mg/1
Pharmacologic classes: 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

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

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 · 86 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	N204629-001	JARDIANCE	10MG	TABLET / ORAL	RLD	2014-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	JARDIANCE	25MG	TABLET / ORAL	RLD, RS	2014-08-01	`84e616aacf4f…`
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…`

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 32 · 1,256 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	N204629-001	7713938	2027-04-15		Drug substance, Drug product	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	7579449	2028-08-01		Drug substance	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	8551957	2029-10-14	U-1651		2016-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12115179	2030-02-11	U-4023		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	8551957*PED	2030-04-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12115179*PED	2030-08-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12527810	2033-04-22	U-4403		2026-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12527810*PED	2033-10-22		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	10258637	2034-04-03	U-2290		2019-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11090323	2034-04-03	U-3191		2021-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11666590	2034-04-03	U-3691		2023-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11813275	2034-04-03	U-3759		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11813275	2034-04-03	U-3760		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11833166	2034-04-03	U-3776		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11833166	2034-04-03	U-3777		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12263153	2034-04-03	U-4171		2025-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12427162	2034-04-03	U-4287		2025-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12433906	2034-04-03	U-4304		2025-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12433906	2034-04-03	U-4293		2025-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12433906	2034-04-03	U-4294		2025-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12433906	2034-04-03	U-4295		2025-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12433906	2034-04-03	U-4296		2025-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	9949997	2034-05-17	U-2292		2018-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	9949997	2034-05-17	U-3325		2018-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	9949997	2034-05-17	U-3199		2018-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	9949998	2034-06-11	U-2290		2018-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	10258637*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11090323*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11813275*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	11833166*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	12433906*PED	2034-10-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	9949997*PED	2034-11-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	9949998*PED	2034-12-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	7713938	2027-04-15		Drug substance, Drug product	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	7713938*PED	2027-10-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	7579449	2028-08-01		Drug substance	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	7579449*PED	2029-02-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	8551957	2029-10-14	U-1651		2016-03-14	`84e616aacf4f…`

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
2026-09-14 22:38:34	2026-08	N204629-001	NPP	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	I-922	2026-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-001	PED	2026-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	NPP	2026-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204629-002	PED	2026-12-20	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EMPAGLIFLOZIN	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1545666	Internal RxNorm lookup
1545668	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
59ed43d9-b4e0-72a2-e063-6394a90a327d	Available on FDA.report

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 ndc (package): 67296-2324-3 ndc (product): 67296-2324 ndc11 (package): 67296232403
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
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
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDC1R2M35U	EMPAGLIFLOZIN	864070-44-0	EMPAGLIFLOZIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67296-2324-3	67296232403	30 TABLET, FILM COATED in 1 BOTTLE (67296-2324-3)	2014-08-01	No	No	Current