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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204629-001	JARDIANCE	10MG	TABLET / ORAL		RLD	2014-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	JARDIANCE	25MG	TABLET / ORAL		RLD, RS	2014-08-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204629-001	7713938	2027-04-15		Drug substance, Drug product	2014-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	7713938*PED	2027-10-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	7579449	2028-08-01		Drug substance	2014-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	7579449*PED	2029-02-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	8551957	2029-10-14	U-1651		2016-03-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12115179	2030-02-11	U-4023		2024-11-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	8551957*PED	2030-04-14		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12115179*PED	2030-08-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12527810	2033-04-22	U-4403		2026-02-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12527810*PED	2033-10-22		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	10258637	2034-04-03	U-2290		2019-04-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11090323	2034-04-03	U-3191		2021-08-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11666590	2034-04-03	U-3691		2023-10-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11813275	2034-04-03	U-3759		2023-12-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11813275	2034-04-03	U-3760		2023-12-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11833166	2034-04-03	U-3776		2024-01-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11833166	2034-04-03	U-3777		2024-01-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12263153	2034-04-03	U-4171		2025-04-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12427162	2034-04-03	U-4287		2025-10-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12433906	2034-04-03	U-4304		2025-10-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12433906	2034-04-03	U-4293		2025-10-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12433906	2034-04-03	U-4294		2025-10-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12433906	2034-04-03	U-4295		2025-10-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12433906	2034-04-03	U-4296		2025-10-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	9949997	2034-05-17	U-2292		2018-05-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	9949997	2034-05-17	U-3325		2018-05-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	9949997	2034-05-17	U-3199		2018-05-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	9949998	2034-06-11	U-2290		2018-05-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	10258637*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11090323*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11813275*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	11833166*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	12433906*PED	2034-10-03		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	9949997*PED	2034-11-17		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	9949998*PED	2034-12-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	7713938	2027-04-15		Drug substance, Drug product	2014-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	7713938*PED	2027-10-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	7579449	2028-08-01		Drug substance	2014-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	7579449*PED	2029-02-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	8551957	2029-10-14	U-1651		2016-03-14	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N204629-001	NPP	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	I-922	2026-09-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-001	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	NPP	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204629-002	PED	2026-12-20	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 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 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