Jentadueto

Product NDC: 0597-0146
Requested package NDC: 0597-0146-66
11-digit product format: 005970146
Labeler code: 0597
Product ID: 0597-0146_f5fe93f0-69ef-4ca2-adeb-c50582e25592
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: linagliptin and metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA201281
Marketing category: NDA
Marketing start: 2012-02-13
Substance: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength: 2.5; 500 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0597-0146	0597-0146-66	D	Discontinued by firm		2026-08-03

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.

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	N201281-001	JENTADUETO	2.5MG;500MG	TABLET / ORAL	AB	RLD	2012-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	JENTADUETO	2.5MG;850MG	TABLET / ORAL	AB	RLD	2012-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	JENTADUETO	2.5MG;1GM	TABLET / ORAL	AB	RLD, RS	2012-01-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N201281-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N201281-001	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10973827	2029-04-02		Drug product	2021-05-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9415016	2029-04-02		Drug product	2016-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10022379*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	10973827*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9415016*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9155705	2030-05-21		Drug product	2015-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8846695	2030-06-04	U-1503		2014-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	9155705*PED	2030-11-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	8846695*PED	2030-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	12364700*PED	2037-12-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10973827	2029-04-02		Drug product	2021-05-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9415016	2029-04-02		Drug product	2016-08-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10022379*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	10973827*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9415016*PED	2029-10-02		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	11911388	2030-04-10	U-3854		2024-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9155705	2030-05-21		Drug product	2015-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8846695	2030-06-04	U-1503		2014-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	9155705*PED	2030-11-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	8846695*PED	2030-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	12364700	2037-06-08	U-4224		2025-07-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	12364700*PED	2037-12-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8883805	2025-11-26		Drug product	2014-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8883805*PED	2026-05-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8673927	2027-05-04	U-1503	Delist requested	2014-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	8673927*PED	2027-11-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	10022379	2029-04-02	U-2339		2018-08-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	10973827	2029-04-02		Drug product	2021-05-05	`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	N201281-001	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-001	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-002	PED	2026-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	M-295	2026-06-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201281-003	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	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 ndc (package): 0597-0146-66 ndc (product): 0597-0146 ndc11 (package): 00597014666

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINAGLIPTIN	2.5 mg/1
METFORMIN HYDROCHLORIDE	500 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1243020	Internal RxNorm lookup
1243026	Internal RxNorm lookup
1243027	Internal RxNorm lookup
1243033	Internal RxNorm lookup
1243034	Internal RxNorm lookup
1243040	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
f6dd9b86-0d18-95d4-2bc7-05591bfdd597	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
0597-0146-18	Jentadueto	180 in 1 BOTTLE	TABLET, FILM COATED	180	45
0597-0146-60	Jentadueto	60 in 1 BOTTLE	TABLET, FILM COATED	60	45
0597-0146-66	Jentadueto	14 in 1 BOTTLE	TABLET, FILM COATED	14	45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0146-18	EA - Each	0597-0146	c6c46dd4-4271-4a4a-bf0d-443a7f63651a	1	2012-07-24
0597-0146-60	EA - Each	0597-0146	ed1c4f8e-e45e-4ff8-8639-ebb8af095444	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
linagliptin	ACTIVE INGREDIENT	3X29ZEJ4R2	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
metformin hydrochloride	ACTIVE INGREDIENT	786Z46389E	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
linagliptin	ACTIVE MOIETY	3X29ZEJ4R2	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
metformin	ACTIVE MOIETY	9100L32L2N	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
arginine	INACTIVE INGREDIENT	94ZLA3W45F	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
copovidone	INACTIVE INGREDIENT	D9C330MD8B	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
talc	INACTIVE INGREDIENT	7SEV7J4R1U	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0146	JENTADUETO (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	45	Current NDC, Legacy NDC, 3 package rows	20240822_f6dd9b86-0d18-95d4-2bc7-05591bfdd597.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
1243026	Jentadueto 2.5 MG / 1000 MG Oral Tablet	PSN	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243033	Jentadueto 2.5 MG / 500 MG Oral Tablet	PSN	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243040	Jentadueto 2.5 MG / 850 MG Oral Tablet	PSN	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243020	linagliptin 2.5 MG / metFORMIN HCl 1000 MG Oral Tablet	PSN	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243027	linagliptin 2.5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243034	linagliptin 2.5 MG / metFORMIN HCl 850 MG Oral Tablet	PSN	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243026	linagliptin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Jentadueto]	SBD	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243033	linagliptin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Jentadueto]	SBD	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243040	linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet [Jentadueto]	SBD	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243020	linagliptin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet	SCD	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243027	linagliptin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243034	linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet	SCD	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243026	Jentadueto 2.5/1000 Oral Tablet	SY	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243033	Jentadueto 2.5/500 Oral Tablet	SY	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45
1243040	Jentadueto 2.5/850 Oral Tablet	SY	f6dd9b86-0d18-95d4-2bc7-05591bfdd597	45

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0146-66	00597014666	14 TABLET, FILM COATED in 1 BOTTLE (0597-0146-66)	2012-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Jentadueto	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| Boehringer Ingelheim Promeco S.A. de C.V. \| VISTIN Pharma AS \| Sixarp, LLC	2024-06-27	HUMAN PRESCRIPTION DRUG LABEL	45