Jardiance

Product NDC: 71610-177
11-digit product format: 716100177
Labeler code: 71610
Product ID: 71610-177_422a084f-5495-2335-e063-6394a90a8736
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Empagliflozin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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: 2026-12-31
Current FDA listing: 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Jardiance
Listing expiration: 2026-12-31

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
8b6261f6-4bdc-462e-8af1-4064664c62f3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
a1e505bd-ab91-46e4-b7bc-a43a10199330	Product name	2	20170214
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
24acbc89-fd6a-458c-aa62-a3485b119bed	Product name	1	20150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-177-09	Jardiance	9000 in 1 BOTTLE	TABLET, FILM COATED	9000	4
71610-177-15	Jardiance	15 in 1 BOTTLE	TABLET, FILM COATED	15	4
71610-177-42	Jardiance	1800 in 1 BOTTLE	TABLET, FILM COATED	1800	4
71610-177-45	Jardiance	45 in 1 BOTTLE	TABLET, FILM COATED	45	4
71610-177-81	Jardiance	1080 in 1 BOTTLE	TABLET, FILM COATED	1080	4
71610-177-99	Jardiance	5040 in 1 BOTTLE	TABLET, FILM COATED	5040	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-177-09	EA - Each	71610-177	d7d7e785-3b97-4c2e-b84f-2914fc2c9ed7	1	2019-01-24
71610-177-15	EA - Each	71610-177	396baa66-67ca-42e9-9106-d315afc3cb3f	1	2025-05-14
71610-177-42	EA - Each	71610-177	e59fc200-04a1-4820-a0b6-276f6d8db682	1	2023-08-08
71610-177-45	EA - Each	71610-177	f8f3e3ec-9110-469d-96dd-23eda06cd676	1	2025-05-14
71610-177-81	EA - Each	71610-177	52083dde-55c2-4cf0-b302-3fdae2c841ab	1	2025-06-13
71610-177-99	EA - Each	71610-177	2c04ed69-bd2a-4912-9c70-afb0bfc1ac59	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-177	JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Current NDC, Legacy NDC, 6 package rows	20250429_8b6261f6-4bdc-462e-8af1-4064664c62f3.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1545666	empagliflozin 25 MG Oral Tablet	PSN	8b6261f6-4bdc-462e-8af1-4064664c62f3	4
1545668	Jardiance 25 MG Oral Tablet	PSN	8b6261f6-4bdc-462e-8af1-4064664c62f3	4
1545668	empagliflozin 25 MG Oral Tablet [Jardiance]	SBD	8b6261f6-4bdc-462e-8af1-4064664c62f3	4
1545666	empagliflozin 25 MG Oral Tablet	SCD	8b6261f6-4bdc-462e-8af1-4064664c62f3	4
1545668	Jardiance 25 MG Oral Tablet	SY	8b6261f6-4bdc-462e-8af1-4064664c62f3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-177-09	71610017709	9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09)	2018-10-24	0000-00-00	No	No	Current
71610-177-15	71610017715	15 TABLET, FILM COATED in 1 BOTTLE (71610-177-15)	2019-09-18		No	No	Current
71610-177-42	71610017742	1800 TABLET, FILM COATED in 1 BOTTLE (71610-177-42)	2022-12-09	0000-00-00	No	No	Current
71610-177-45	71610017745	45 TABLET, FILM COATED in 1 BOTTLE (71610-177-45)	2019-10-03		No	No	Current
71610-177-81	71610017781	1080 TABLET, FILM COATED in 1 BOTTLE (71610-177-81)	2025-04-22		No	No	Current
71610-177-99	71610017799	5040 TABLET, FILM COATED in 1 BOTTLE (71610-177-99)	2025-10-27		No	No	Current