telmisartan

Product NDC: 68071-2591
Requested package NDC: 68071-2591-3
11-digit product format: 680712591
Labeler code: 68071
Product ID: 68071-2591_d28021ac-24bc-3da6-e053-2995a90ac24c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA205150
Marketing category: ANDA
Marketing start: 2016-06-12
Marketing end: 0000-00-00
Substance: TELMISARTAN
Active strength: 80 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68071-2591	68071-2591-3	I	Inactivated by FDA		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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A205150-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30
A205150-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30
A205150-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205150-001	AB
A205150-002	AB
A205150-003	AB

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	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB	RS	2015-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-002	TELMISARTAN	40MG	TABLET / ORAL	AB		2015-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-003	TELMISARTAN	80MG	TABLET / ORAL	AB		2015-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205150-001	TELMISARTAN	20MG	TABLET / ORAL	AB		2015-10-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A205150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205150-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205150-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205150-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205150-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205150-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205150-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205150-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205150-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205150-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205150-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205150-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205150-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205150-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205150-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
796916df-49fa-d043-64a7-fee11194676c	Product name	9	20171130
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2591-3	2025-01-30	C162847	48780-1	f386c64a-3c48-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
68071-2591-3	2023-07-17	C162847	48780-1	f386c64a-3c48-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
68071-2591-3	2023-01-30	C162847	48780-1	f386c64a-3c48-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2591-3	telmisartan	30 in 1 BOTTLE	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2591	TELMISARTAN TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 1 package rows	20230718_d28021ac-24bb-3da6-e053-2995a90ac24c.zip

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
telmisartan	TELMISARTAN	REMEDYREPACK INC.	09d31eee-cd22-4918-a889-3eb4d2969525	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	f6da5155-9c26-46bb-bc0f-ece4ea21405f	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	dd2b0604-f887-40d9-9109-dafcc9987e4e	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	963e9245-ec7a-4bf6-9fc0-80f54e3657f0	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	PD-Rx Pharmaceuticals, Inc.	56a72ddf-c2a2-45ce-91b1-1fcfbff52c10	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Bryant Ranch Prepack	32489e86-0432-4d74-92f6-15e7450f52fa	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Bryant Ranch Prepack	44e810d4-cf04-41d3-bdf8-0681210a669f	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Ascend Laboratories, LLC	29bddc43-2809-4e1f-ae35-2865e15e9bb6	2025-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150
telmisartan	TELMISARTAN	Proficient Rx LP	593a53a4-91bc-4e4a-aeff-08fc2efe3dd4	2020-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205150 application number: ANDA205150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U5SYW473RQ	TELMISARTAN	144701-48-4	TELMISARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205305	telmisartan 80 MG Oral Tablet	PSN	d28021ac-24bb-3da6-e053-2995a90ac24c	2
205305	telmisartan 80 MG Oral Tablet	SCD	d28021ac-24bb-3da6-e053-2995a90ac24c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2591-3	68071259103	30 TABLET in 1 BOTTLE (68071-2591-3)	30 tablet	2021-12-06	0000-00-00	No	No	Current