Twynsta

Product NDC: 0597-0125
11-digit product format: 005970125
Labeler code: 0597
Product ID: 0597-0125_852d4f05-25e5-9785-0514-2826b363cf96
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: telmisartan/amlodipine
Dosage form: TABLET, MULTILAYER
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA022401
Marketing category: NDA
Marketing start: 2009-11-02
Marketing end: 0000-00-00
Substance: TELMISARTAN; AMLODIPINE BESYLATE
Active strength: 40 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [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	0597-0125		D	Discontinued by firm		2026-08-03
excluded package	package	0597-0125	0597-0125-37	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022401-001	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16
N022401-002	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16
N022401-003	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16
N022401-004	TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022401-001	TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022401-002	TWYNSTA	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022401-003	TWYNSTA	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022401-004	TWYNSTA	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2009-10-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022401-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022401-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022401-004	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022401-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022401-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022401-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022401-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022401-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022401-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022401-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022401-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022401-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022401-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022401-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022401-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022401-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022401-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022401-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022401-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022401-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022401-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022401-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022401-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022401-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022401-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022401-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022401-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022401-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022401-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022401-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022401-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022401-004	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0125-37	EA - Each	0597-0125	b03c8108-0e31-4eb8-91e4-774ad33f2712	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	TWYNSTA (TELMISARTAN/AMLODIPINE) TABLET, MULTILAYER [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	25
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	TWYNSTA (TELMISARTAN/AMLODIPINE) TABLET, MULTILAYER [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	25
AMLODIPINE	ACTIVE MOIETY	1J444QC288	TWYNSTA (TELMISARTAN/AMLODIPINE) TABLET, MULTILAYER [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	25
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	TWYNSTA (TELMISARTAN/AMLODIPINE) TABLET, MULTILAYER [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	25

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U5SYW473RQ	TELMISARTAN	144701-48-4	TELMISARTAN
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0125-37	00597012537	3 BLISTER PACK in 1 CARTON (0597-0125-37) > 10 TABLET, MULTILAYER in 1 BLISTER PACK	3 blister pack	2009-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Twynsta	Boehringer Ingelheim Pharmaceuticals, Inc. \| Cipla Kurkumbh \| Cipla Bangalore \| Boehringer Ingelheim Pharma GmbH and Co. KG \| Cipla Limited \| Malgrat Pharma Chemicals, S.L.U.	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	29