Jentadueto

Product NDC: 63629-6524
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

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

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 8 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	63629-6524		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-6524	63629-6524-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	63629-6524		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-6524	63629-6524-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	63629-6524		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-6524	63629-6524-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	63629-6524		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-6524	63629-6524-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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…`

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 · 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

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

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