TELMISARTAN

Product NDC: 42571-226
Requested package NDC: 42571-226-05
11-digit product format: 425710226
Labeler code: 42571
Product ID: 42571-226_f2aa8284-f86c-3425-e053-2995a90a6dc6
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
Substance: TELMISARTAN
Active strength: 20 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	42571-226	42571-226-05	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207016-001	AB
A207016-002	AB
A207016-003	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 · 126 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
2026-08-18 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207016-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-10-03	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207016-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207016-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207016-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207016-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207016-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207016-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207016-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207016-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207016-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207016-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207016-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207016-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207016-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207016-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207016-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207016-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207016-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207016-001	AB	1	`1e350fbaab3a…`

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
42571-226-05	TELMISARTAN	500 in 1 BOTTLE	TABLET	500	14
42571-226-10	TELMISARTAN	1000 in 1 BOTTLE	TABLET	1000	14
42571-226-11	TELMISARTAN	10 in 1 CARTON	TABLET	10	14
42571-226-30	TELMISARTAN	30 in 1 BOTTLE	TABLET	30	14
42571-226-32	TELMISARTAN	10 in 1 BLISTER PACK	TABLET	10	14
42571-226-41	TELMISARTAN	3 in 1 CARTON	TABLET	3	14
42571-226-90	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
42571-226-30	EA - Each	42571-226	8b94070f-edec-4f53-b24a-6bb48792dfd4	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-226	TELMISARTAN (TELMISARTAN) TABLET [MICRO LABS LIMITED]	14	Current NDC, 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
42571-226-05	42571022605	500 TABLET in 1 BOTTLE (42571-226-05)	500 tablet	2018-01-01	0000-00-00	No	No	Current