TELMISARTAN

Product NDC: 42571-227
11-digit product format: 425710227
Labeler code: 42571
Product ID: 42571-227_d1e62364-2b75-d7f8-e053-2995a90aec6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA207016
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: TELMISARTAN
Active strength: 40 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42571-227		D	Discontinued by firm	2026-10-15
excluded package	package	42571-227	42571-227-05	D	Discontinued by firm	2026-10-15
excluded package	package	42571-227	42571-227-10	D	Discontinued by firm	2026-10-15
excluded package	package	42571-227	42571-227-11	D	Discontinued by firm	2026-10-15
excluded package	package	42571-227	42571-227-30	D	Discontinued by firm	2026-10-15
excluded package	package	42571-227	42571-227-41	D	Discontinued by firm	2026-10-15
excluded package	package	42571-227	42571-227-90	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A207016-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	2017-10-03
A207016-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	2017-10-03
A207016-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	2017-10-03

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207016-001	TELMISARTAN	20MG	TABLET / ORAL		2017-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207016-002	TELMISARTAN	40MG	TABLET / ORAL		2017-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207016-003	TELMISARTAN	80MG	TABLET / ORAL		2017-10-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207016-001	TELMISARTAN	20MG	TABLET / ORAL		2017-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207016-002	TELMISARTAN	40MG	TABLET / ORAL		2017-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207016-003	TELMISARTAN	80MG	TABLET / ORAL		2017-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207016-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207016-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207016-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207016-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207016-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207016-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207016-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207016-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207016-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207016-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207016-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207016-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207016-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207016-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207016-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207016-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207016-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207016-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207016-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207016-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207016-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207016-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207016-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207016-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207016-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207016-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207016-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207016-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207016-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207016-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207016-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207016-003	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207016-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207016-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207016-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207016-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207016-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207016-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207016-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207016-002	AB	1	`ea1830bbd6c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-227-05	TELMISARTAN	500 in 1 BOTTLE	TABLET	500	14
42571-227-10	TELMISARTAN	1000 in 1 BOTTLE	TABLET	1000	14
42571-227-11	TELMISARTAN	10 in 1 CARTON	TABLET	10	14
42571-227-30	TELMISARTAN	30 in 1 BOTTLE	TABLET	30	14
42571-227-32	TELMISARTAN	10 in 1 BLISTER PACK	TABLET	10	14
42571-227-41	TELMISARTAN	3 in 1 CARTON	TABLET	3	14
42571-227-90	TELMISARTAN	90 in 1 BOTTLE	TABLET	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-227-30	EA - Each	42571-227	fbb64ae4-d011-4ca0-a948-f504146fcb32	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-227	TELMISARTAN (TELMISARTAN) TABLET [MICRO LABS LIMITED]	14	Legacy NDC, 7 package rows	20230121_d7c9bd41-9558-46e1-ab03-82cdf85db3fe.zip

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
282755	telmisartan 20 MG Oral Tablet	PSN	d7c9bd41-9558-46e1-ab03-82cdf85db3fe	14
205304	telmisartan 40 MG Oral Tablet	PSN	d7c9bd41-9558-46e1-ab03-82cdf85db3fe	14
205305	telmisartan 80 MG Oral Tablet	PSN	d7c9bd41-9558-46e1-ab03-82cdf85db3fe	14
282755	telmisartan 20 MG Oral Tablet	SCD	d7c9bd41-9558-46e1-ab03-82cdf85db3fe	14
205304	telmisartan 40 MG Oral Tablet	SCD	d7c9bd41-9558-46e1-ab03-82cdf85db3fe	14
205305	telmisartan 80 MG Oral Tablet	SCD	d7c9bd41-9558-46e1-ab03-82cdf85db3fe	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-227-05	42571022705	500 TABLET in 1 BOTTLE (42571-227-05)	500 tablet	2018-01-01	0000-00-00	No	No	Current
42571-227-10	42571022710	1000 TABLET in 1 BOTTLE (42571-227-10)	1000 tablet	2018-01-01	0000-00-00	No	No	Current
42571-227-11	42571022711	10 BLISTER PACK in 1 CARTON (42571-227-11) > 10 TABLET in 1 BLISTER PACK (42571-227-32)	10 blister pack	2018-01-01	0000-00-00	No	No	Current
42571-227-30	42571022730	30 TABLET in 1 BOTTLE (42571-227-30)	30 tablet	2018-01-01	0000-00-00	No	No	Current
42571-227-32	42571022732	10 in 1 BLISTER PACK						Historical
42571-227-41	42571022741	3 TABLET in 1 CARTON (42571-227-41)	3 tablet	2018-01-01	0000-00-00	No	No	Current
42571-227-90	42571022790	90 TABLET in 1 BOTTLE (42571-227-90)	90 tablet	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TELMISARTAN	Micro Labs Limited	2023-01-19	HUMAN PRESCRIPTION DRUG LABEL	14
TELMISARTAN	Bryant Ranch Prepack	2022-02-14	HUMAN PRESCRIPTION DRUG LABEL	101