Jentadueto

Product NDC: 63629-6524
Requested package NDC: 63629-6524-1
11-digit product format: 636296524
Labeler code: 63629
Product ID: 63629-6524_b81bd234-7dcb-4bf5-8396-38f8a39d0ea1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linagliptin and metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA201281
Marketing category: NDA
Marketing start: 2012-02-13
Marketing end: 0000-00-00
Substance: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength: 3 mg/1; g/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-6524	63629-6524-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201281-001	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30
N201281-002	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30
N201281-003	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N201281-001	AB
N201281-002	AB
N201281-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 51 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201281-001	8883805	2025-11-26		Drug product	2014-12-09
N201281-001	8883805*PED	2026-05-26		Pediatric extension
N201281-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201281-001	8673927*PED	2027-11-04		Pediatric extension
N201281-001	10022379	2029-04-02	U-2339		2018-08-06
N201281-001	10973827	2029-04-02		Drug product	2021-05-05
N201281-001	9415016	2029-04-02		Drug product	2016-08-30
N201281-001	10022379*PED	2029-10-02		Pediatric extension
N201281-001	10973827*PED	2029-10-02		Pediatric extension
N201281-001	9415016*PED	2029-10-02		Pediatric extension
N201281-001	11911388	2030-04-10	U-3854		2024-03-25
N201281-001	9155705	2030-05-21		Drug product	2015-10-21
N201281-001	8846695	2030-06-04	U-1503		2014-10-21
N201281-001	9155705*PED	2030-11-21		Pediatric extension
N201281-001	8846695*PED	2030-12-04		Pediatric extension
N201281-001	12364700	2037-06-08	U-4224		2025-07-31
N201281-001	12364700*PED	2037-12-08		Pediatric extension
N201281-002	8883805	2025-11-26		Drug product	2014-12-09
N201281-002	8883805*PED	2026-05-26		Pediatric extension
N201281-002	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201281-002	8673927*PED	2027-11-04		Pediatric extension
N201281-002	10022379	2029-04-02	U-2339		2018-08-06
N201281-002	10973827	2029-04-02		Drug product	2021-05-05
N201281-002	9415016	2029-04-02		Drug product	2016-08-30
N201281-002	10022379*PED	2029-10-02		Pediatric extension
N201281-002	10973827*PED	2029-10-02		Pediatric extension
N201281-002	9415016*PED	2029-10-02		Pediatric extension
N201281-002	11911388	2030-04-10	U-3854		2024-03-25
N201281-002	9155705	2030-05-21		Drug product	2015-10-21
N201281-002	8846695	2030-06-04	U-1503		2014-10-21
N201281-002	9155705*PED	2030-11-21		Pediatric extension
N201281-002	8846695*PED	2030-12-04		Pediatric extension
N201281-002	12364700	2037-06-08	U-4224		2025-07-31
N201281-002	12364700*PED	2037-12-08		Pediatric extension
N201281-003	8883805	2025-11-26		Drug product	2014-12-09
N201281-003	8883805*PED	2026-05-26		Pediatric extension
N201281-003	8673927	2027-05-04	U-1503	Delist requested	2014-04-15
N201281-003	8673927*PED	2027-11-04		Pediatric extension
N201281-003	10022379	2029-04-02	U-2339		2018-08-06
N201281-003	10973827	2029-04-02		Drug product	2021-05-05
N201281-003	9415016	2029-04-02		Drug product	2016-08-30
N201281-003	10022379*PED	2029-10-02		Pediatric extension
N201281-003	10973827*PED	2029-10-02		Pediatric extension
N201281-003	9415016*PED	2029-10-02		Pediatric extension
N201281-003	11911388	2030-04-10	U-3854		2024-03-25
N201281-003	9155705	2030-05-21		Drug product	2015-10-21
N201281-003	8846695	2030-06-04	U-1503	Delist requested	2014-10-21
N201281-003	9155705*PED	2030-11-21		Pediatric extension
N201281-003	8846695*PED	2030-12-04		Pediatric extension
N201281-003	12364700	2037-06-08	U-4224		2025-07-31
N201281-003	12364700*PED	2037-12-08		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N201281-001	M-295	2026-06-20
N201281-001	PED	2026-12-20
N201281-002	M-295	2026-06-20
N201281-002	PED	2026-12-20
N201281-003	M-295	2026-06-20
N201281-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201281-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201281-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201281-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201281-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201281-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201281-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201281-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201281-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201281-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201281-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 43 · 1,710 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201281-001	8883805	2025-11-26		Drug product	2014-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	8673927*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	10022379	2029-04-02	U-2339		2018-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	10973827	2029-04-02		Drug product	2021-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	9415016	2029-04-02		Drug product	2016-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	10022379*PED	2029-10-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	10973827*PED	2029-10-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	9415016*PED	2029-10-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	11911388	2030-04-10	U-3854		2024-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	9155705	2030-05-21		Drug product	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	8846695	2030-06-04	U-1503		2014-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	9155705*PED	2030-11-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	8846695*PED	2030-12-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	12364700	2037-06-08	U-4224		2025-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	12364700*PED	2037-12-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	8883805	2025-11-26		Drug product	2014-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	8673927*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	10022379	2029-04-02	U-2339		2018-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	10973827	2029-04-02		Drug product	2021-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	9415016	2029-04-02		Drug product	2016-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	10022379*PED	2029-10-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	10973827*PED	2029-10-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	9415016*PED	2029-10-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	11911388	2030-04-10	U-3854		2024-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	9155705	2030-05-21		Drug product	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	8846695	2030-06-04	U-1503		2014-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	9155705*PED	2030-11-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	8846695*PED	2030-12-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	12364700	2037-06-08	U-4224		2025-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	12364700*PED	2037-12-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	8883805	2025-11-26		Drug product	2014-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	8673927*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	10022379	2029-04-02	U-2339		2018-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	10973827	2029-04-02		Drug product	2021-05-05	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 222 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201281-001	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-001	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-002	PED	2026-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	M-295	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201281-003	PED	2026-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-001	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-002	PED	2026-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	M-295	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201281-003	PED	2026-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201281-001	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-001	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-002	PED	2026-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	M-295	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201281-003	PED	2026-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-001	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-002	PED	2026-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-003	M-295	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201281-003	PED	2026-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-001	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-001	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-002	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-002	PED	2026-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-003	M-295	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201281-003	PED	2026-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-001	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-001	PED	2026-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-002	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-002	PED	2026-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-003	M-295	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201281-003	PED	2026-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-001	M-295	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-001	PED	2026-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-002	M-295	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201281-002	PED	2026-12-20	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-6524-1	2021-06-11	C162847	48780-1	9d75b9d0-2923-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. JENTADUETO® (linagliptin and metformin hydrochloride tablets), for oral use Initial U.S. Approval: 2012
63629-6524-1	2020-01-31	C162847	48780-1	9d75b9d0-2923-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. JENTADUETO® (linagliptin and metformin hydrochloride tablets), for oral use Initial U.S. Approval: 2012

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jentadueto	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	2024-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201281 application number: NDA201281

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X29ZEJ4R2	LINAGLIPTIN	668270-12-0	LINAGLIPTIN
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6524-1	63629652401	60 TABLET, FILM COATED in 1 BOTTLE (63629-6524-1)	2015-07-27	0000-00-00	No	No	Current