Tradjenta

Product NDC: 0597-0140
11-digit product format: 005970140
Labeler code: 0597
Product ID: 0597-0140_80d5d700-e711-462e-b291-3684a78d00b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linagliptin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA201280
Marketing category: NDA
Marketing start: 2011-05-09
Substance: LINAGLIPTIN
Active strength: 5 mg/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201280-001	TRADJENTA	LINAGLIPTIN	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N201280-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201280-001	8883805	2025-11-26		Drug product	2014-12-09
N201280-001	8883805*PED	2026-05-26		Pediatric extension
N201280-001	11033552	2027-05-04		Drug product	2021-07-09
N201280-001	12178819	2027-05-04		Drug product	2025-01-24
N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201280-001	11033552*PED	2027-11-04		Pediatric extension
N201280-001	8673927*PED	2027-11-04		Pediatric extension
N201280-001	10034877	2029-08-05	U-2347		2018-08-10
N201280-001	9486526	2029-08-05	U-1915		2016-11-18
N201280-001	10034877*PED	2030-02-05		Pediatric extension
N201280-001	9486526*PED	2030-02-05		Pediatric extension
N201280-001	11911388	2030-04-10	U-3854		2024-03-25
N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21
N201280-001	8846695*PED	2030-12-04		Pediatric extension
N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23
N201280-001	8853156*PED	2031-09-05		Pediatric extension
N201280-001	12364700	2037-06-08	U-4224		2025-07-31
N201280-001	12364700*PED	2037-12-08		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N201280-001	M-295	2026-06-20
N201280-001	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 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL		RLD, RS	2011-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201280-001	TRADJENTA	5MG	TABLET / ORAL	AB	RLD, RS	2011-05-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N201280-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201280-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201280-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201280-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201280-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201280-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201280-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201280-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201280-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201280-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201280-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201280-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201280-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201280-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201280-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201280-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201280-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201280-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201280-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201280-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201280-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201280-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 706 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	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	11033552	2027-05-04		Drug product	2021-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	12178819	2027-05-04		Drug product	2025-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	11033552*PED	2027-11-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8673927*PED	2027-11-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	10034877	2029-08-05	U-2347		2018-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	9486526	2029-08-05	U-1915		2016-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	10034877*PED	2030-02-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	9486526*PED	2030-02-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	11911388	2030-04-10	U-3854		2024-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8846695*PED	2030-12-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	8853156*PED	2031-09-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	12364700	2037-06-08	U-4224		2025-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	12364700*PED	2037-12-08		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	11033552	2027-05-04		Drug product	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	12178819	2027-05-04		Drug product	2025-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	11033552*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8673927*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	10034877	2029-08-05	U-2347		2018-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	9486526	2029-08-05	U-1915		2016-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	10034877*PED	2030-02-05		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	9486526*PED	2030-02-05		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	11911388	2030-04-10	U-3854		2024-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8846695	2030-06-04	U-1503	Delist requested	2014-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8846695*PED	2030-12-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8853156	2031-03-05	U-1642	Drug product	2015-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	8853156*PED	2031-09-05		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	12364700	2037-06-08	U-4224		2025-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	12364700*PED	2037-12-08		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	7407955	2025-05-02		Drug substance, Drug product	2011-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	7407955*PED	2025-11-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	8883805	2025-11-26		Drug product	2014-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	8883805*PED	2026-05-26		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 76 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	N201280-001	M-295	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201280-001	PED	2026-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201280-001	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201280-001	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201280-001	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201280-001	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201280-001	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201280-001	PED	2026-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201280-001	PED	2026-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201280-001	PED	2026-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	M-295	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201280-001	PED	2026-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	M-295	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201280-001	PED	2026-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	M-295	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201280-001	PED	2026-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201280-001	M-295	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201280-001	PED	2026-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	M-295	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201280-001	PED	2026-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	M-295	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201280-001	PED	2026-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	M-295	2026-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201280-001	PED	2026-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201280-001	M-295	2026-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201280-001	PED	2026-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	M-258	2022-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201280-001	M-252	2023-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201280-001	M-258	2022-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201280-001	M-252	2023-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201280-001	M-258	2022-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201280-001	M-252	2023-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201280-001	M-258	2022-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201280-001	M-252	2023-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201280-001	M-258	2022-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201280-001	M-252	2023-03-30	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINAGLIPTIN	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X29ZEJ4R2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1100702	Internal RxNorm lookup
1100706	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
c797ea5c-cab7-494b-9044-27eba0cfe40f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b15b11c6-be06-b86a-2026-0a2ad3876555	Product name	3	20250429
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
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
0597-0140-30	Tradjenta	30 in 1 BOTTLE	TABLET, FILM COATED	30	32
0597-0140-61	Tradjenta	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	32
0597-0140-61	Tradjenta	100 in 1 CARTON	TABLET, FILM COATED	100	32
0597-0140-70	Tradjenta	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	32
0597-0140-70	Tradjenta	7 in 1 CARTON	TABLET, FILM COATED	7	32
0597-0140-90	Tradjenta	90 in 1 BOTTLE	TABLET, FILM COATED	90	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0140-30	EA - Each	0597-0140	ea14afe5-22bd-4b0a-bc02-88bccfca4be6	1	2012-07-24
0597-0140-61	EA - Each	0597-0140	5c6d1e79-e4bc-4510-b89a-87d3f5ac3057	1	2012-07-24
0597-0140-90	EA - Each	0597-0140	f0fe977b-e10c-4559-873e-d4642012705e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
linagliptin	ACTIVE INGREDIENT	3X29ZEJ4R2	TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	20
linagliptin	ACTIVE MOIETY	3X29ZEJ4R2	TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	20
linagliptin	ACTIVE INGREDIENT	3X29ZEJ4R2	TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	1
linagliptin	ACTIVE MOIETY	3X29ZEJ4R2	TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0140	TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	32	Current NDC, Legacy NDC, 6 package rows	20250327_c797ea5c-cab7-494b-9044-27eba0cfe40f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tradjenta	LINAGLIPTIN	Cardinal Health 107, LLC	dfe327e8-f6ab-41e5-bdef-d520118cd83a	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201280 application number: NDA201280
Tradjenta	LINAGLIPTIN	Boehringer Ingelheim Pharmaceuticals, Inc.	c797ea5c-cab7-494b-9044-27eba0cfe40f	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201280 application number: NDA201280 ndc (product): 0597-0140
Tradjenta	LINAGLIPTIN	A-S Medication Solutions	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201280 application number: NDA201280

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X29ZEJ4R2	LINAGLIPTIN	668270-12-0	LINAGLIPTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1100702	linagliptin 5 MG Oral Tablet	PSN	c797ea5c-cab7-494b-9044-27eba0cfe40f	32
1100706	Tradjenta 5 MG Oral Tablet	PSN	c797ea5c-cab7-494b-9044-27eba0cfe40f	32
1100706	linagliptin 5 MG Oral Tablet [Tradjenta]	SBD	c797ea5c-cab7-494b-9044-27eba0cfe40f	32
1100702	linagliptin 5 MG Oral Tablet	SCD	c797ea5c-cab7-494b-9044-27eba0cfe40f	32
1100706	Tradjenta 5 MG Oral Tablet	SY	c797ea5c-cab7-494b-9044-27eba0cfe40f	32
1100702	linagliptin 5 MG Oral Tablet	PSN	dfe327e8-f6ab-41e5-bdef-d520118cd83a	12
1100706	Tradjenta 5 MG Oral Tablet	PSN	dfe327e8-f6ab-41e5-bdef-d520118cd83a	12
1100706	linagliptin 5 MG Oral Tablet [Tradjenta]	SBD	dfe327e8-f6ab-41e5-bdef-d520118cd83a	12
1100702	linagliptin 5 MG Oral Tablet	SCD	dfe327e8-f6ab-41e5-bdef-d520118cd83a	12
1100706	Tradjenta 5 MG Oral Tablet	SY	dfe327e8-f6ab-41e5-bdef-d520118cd83a	12
1100702	linagliptin 5 MG Oral Tablet	PSN	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	8
1100706	Tradjenta 5 MG Oral Tablet	PSN	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	8
1100706	linagliptin 5 MG Oral Tablet [Tradjenta]	SBD	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	8
1100702	linagliptin 5 MG Oral Tablet	SCD	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	8
1100706	Tradjenta 5 MG Oral Tablet	SY	b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0140-30	00597014030	30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)		2011-05-09	0000-00-00	No	No	Current
0597-0140-61	00597014061	100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2011-05-09	0000-00-00	No	No	Current
0597-0140-70	00597014070	7 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK	7 blister pack	2011-05-09	2026-08-31	Yes	No	Current
0597-0140-90	00597014090	90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)		2011-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tradjenta	Cardinal Health 107, LLC	2025-08-27	HUMAN PRESCRIPTION DRUG LABEL	12
Tradjenta	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc. \| Boehringer Ingelheim Promeco, S.A. de C.V. \| Sixarp, LLC \| Bidachem S.p.a.	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	32
Tradjenta	A-S Medication Solutions	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	8