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 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
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

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

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