Jentadueto XR

Product NDC: 0597-0270
11-digit product format: 005970270
Labeler code: 0597
Product ID: 0597-0270_bded948b-6ae6-41aa-bc63-9600660a8dfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linagliptin and metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA208026
Marketing category: NDA
Marketing start: 2016-05-27
Substance: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength: 2.5; 1000 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], 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 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
N208026-001	JENTADUETO XR	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-05-27
N208026-002	JENTADUETO XR	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208026-001	8883805	2025-11-26		Drug product	2016-06-22
N208026-001	8883805*PED	2026-05-26		Pediatric extension
N208026-001	8673927	2027-05-04	U-1503	Delist requested	2016-06-22
N208026-001	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22
N208026-001	8673927*PED	2027-11-04		Pediatric extension
N208026-001	9173859*PED	2027-11-04		Pediatric extension
N208026-001	10022379	2029-04-02	U-2339		2018-08-06
N208026-001	9415016	2029-04-02		Drug product	2016-08-30
N208026-001	10022379*PED	2029-10-02		Pediatric extension
N208026-001	9415016*PED	2029-10-02		Pediatric extension
N208026-001	11911388	2030-04-10	U-3854		2024-03-25
N208026-001	9155705	2030-05-21		Drug product	2016-06-22
N208026-001	9155705*PED	2030-11-21		Pediatric extension
N208026-001	9555001	2033-03-06	U-1967	Drug product	2017-02-22
N208026-001	9555001	2033-03-06	U-1968	Drug product	2017-02-22
N208026-001	9555001*PED	2033-09-06		Pediatric extension
N208026-001	12364700	2037-06-08	U-4224		2025-07-31
N208026-001	12364700*PED	2037-12-08		Pediatric extension
N208026-002	8883805	2025-11-26		Drug product	2016-06-22
N208026-002	8883805*PED	2026-05-26		Pediatric extension
N208026-002	8673927	2027-05-04	U-1503	Delist requested	2016-06-22
N208026-002	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22
N208026-002	8673927*PED	2027-11-04		Pediatric extension
N208026-002	9173859*PED	2027-11-04		Pediatric extension
N208026-002	10022379	2029-04-02	U-2339		2018-08-06
N208026-002	9415016	2029-04-02		Drug product	2016-08-30
N208026-002	10022379*PED	2029-10-02		Pediatric extension
N208026-002	9415016*PED	2029-10-02		Pediatric extension
N208026-002	11911388	2030-04-10	U-3854		2024-03-25
N208026-002	9155705	2030-05-21		Drug product	2016-06-22
N208026-002	9155705*PED	2030-11-21		Pediatric extension
N208026-002	9555001	2033-03-06	U-1967	Drug product	2017-02-22
N208026-002	9555001	2033-03-06	U-1968	Drug product	2017-02-22
N208026-002	9555001*PED	2033-09-06		Pediatric extension
N208026-002	12364700	2037-06-08	U-4224		2025-07-31
N208026-002	12364700*PED	2037-12-08		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208026-001	M-295	2026-06-20
N208026-001	PED	2026-12-20
N208026-002	M-295	2026-06-20
N208026-002	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	N208026-001	JENTADUETO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2016-05-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	JENTADUETO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2016-05-27	`a50c72e98297…`

Observed Orange Book patent history#

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	N208026-001	8883805	2025-11-26		Drug product	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	8673927	2027-05-04	U-1503	Delist requested	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9173859*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9415016	2029-04-02		Drug product	2016-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	10022379*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9415016*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9155705	2030-05-21		Drug product	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9155705*PED	2030-11-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9555001	2033-03-06	U-1967	Drug product	2017-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9555001	2033-03-06	U-1968	Drug product	2017-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	9555001*PED	2033-09-06		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	12364700*PED	2037-12-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	8883805	2025-11-26		Drug product	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	8673927	2027-05-04	U-1503	Delist requested	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9173859	2027-05-04	U-1503	Drug product, Delist requested	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9173859*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9415016	2029-04-02		Drug product	2016-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	10022379*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9415016*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9155705	2030-05-21		Drug product	2016-06-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9155705*PED	2030-11-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9555001	2033-03-06	U-1968	Drug product	2017-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9555001	2033-03-06	U-1967	Drug product	2017-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	9555001*PED	2033-09-06		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	12364700*PED	2037-12-08		Pediatric extension		`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	N208026-001	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-001	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208026-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jentadueto XR	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208026 application number: NDA208026 ndc (product): 0597-0270

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINAGLIPTIN	2.5 mg/1
METFORMIN HYDROCHLORIDE	1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup
3X29ZEJ4R2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1796089	Internal RxNorm lookup
1796091	Internal RxNorm lookup
1796094	Internal RxNorm lookup
1796096	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
3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
b15b11c6-be06-b86a-2026-0a2ad3876555	Product name	3	20250429
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
24acbc89-fd6a-458c-aa62-a3485b119bed	Product name	1	20150323
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0597-0270-12	Jentadueto XR	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	9
0597-0270-12	Jentadueto XR	14 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	14	9
0597-0270-73	Jentadueto XR	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	9
0597-0270-94	Jentadueto XR	180 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	180	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0270-73	EA - Each	0597-0270	4c7d06d2-9a85-436a-9440-b33483f0f488	1	2016-07-19
0597-0270-94	EA - Each	0597-0270	95afc229-cf6b-40ff-aae4-0f057499f495	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0270	JENTADUETO XR (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20240606_3d02a4d4-d312-80b4-05c4-691b8f0aa7aa.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1796091	Jentadueto XR 2.5 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796096	Jentadueto XR 5 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796089	linagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796094	linagliptin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796091	24 HR linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Jentadueto]	SBD	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796096	24 HR linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Jentadueto]	SBD	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796089	24 HR linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796094	24 HR linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796091	Jentadueto XR (linagliptin 2.5 MG / metformin HCl 1000 MG) 24HR Extended Release Oral Tablet	SY	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796096	Jentadueto XR (linagliptin 5 MG / metformin HCl 1000 MG) 24HR Extended Release Oral Tablet	SY	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796089	linagliptin 2.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9
1796094	linagliptin 5 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	3d02a4d4-d312-80b4-05c4-691b8f0aa7aa	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0270-12	00597027012	1 BOTTLE in 1 CARTON (0597-0270-12) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2016-05-27	0000-00-00	No	No	Current
0597-0270-73	00597027073	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73)		2016-05-27	0000-00-00	No	No	Current
0597-0270-94	00597027094	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-94)		2016-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Jentadueto XR	Boehringer Ingelheim Pharmaceuticals, Inc. \| Patheon Pharmaceuticals Inc. \| Sixarp, LLC	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	9