Telmisartan

Product NDC: 72241-015
11-digit product format: 722410015
Labeler code: 72241
Product ID: 72241-015_2d61b730-b379-49e1-877a-d14c92ab5b23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Modavar Pharmaceuticals LLC
Application: ANDA208605
Marketing category: ANDA
Marketing start: 2015-02-05
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

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	Approval date
A208605-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25
A208605-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25
A208605-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208605-001	AB
A208605-002	AB
A208605-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`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	A208605-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208605-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208605-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208605-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208605-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208605-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208605-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208605-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208605-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208605-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208605-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208605-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208605-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208605-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208605-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208605-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208605-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208605-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208605-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208605-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208605-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208605-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208605-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208605-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208605-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208605-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208605-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208605-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208605-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208605-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208605-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208605-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208605-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208605-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208605-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208605-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208605-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208605-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208605-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208605-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U5SYW473RQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205304	Internal RxNorm lookup
205305	Internal RxNorm lookup
282755	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
a075633a-2a2a-4e88-8ede-b49a3920a16c	Available on FDA.report

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
72241-015-04	Telmisartan	90 in 1 BOTTLE	TABLET	90	4
72241-015-05	Telmisartan	100 in 1 BOTTLE	TABLET	100	4
72241-015-10	Telmisartan	500 in 1 BOTTLE	TABLET	500	4
72241-015-11	Telmisartan	1000 in 1 BOTTLE	TABLET	1000	4
72241-015-16	Telmisartan	30 in 1 CARTON	TABLET	30	4
72241-015-16	Telmisartan	10 in 1 BLISTER PACK	TABLET	10	4
72241-015-18	Telmisartan	30 in 1 CARTON	TABLET	30	4
72241-015-18	Telmisartan	10 in 1 BLISTER PACK	TABLET	10	4
72241-015-22	Telmisartan	30 in 1 BOTTLE	TABLET	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72241-015-01	EA - Each	72241-015	53562254-dfed-4a4d-9412-5f75148d9523	1	2023-03-13
72241-015-22	EA - Each	72241-015	ed5c2450-c0d5-4995-ae86-1cfed48d4d59	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72241-015	TELMISARTAN TABLET [MODAVAR PHARMACEUTICALS LLC]	4	Current NDC, Legacy NDC, 9 package rows	20231004_a075633a-2a2a-4e88-8ede-b49a3920a16c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	e2deff49-b75e-4aaa-8114-d5ea1e3a94a5	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208605 application number: ANDA208605
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	b4ae8694-2af4-4acb-8634-b40c1cb6fb41	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208605 application number: ANDA208605
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	f13e0919-5ee2-4855-b7c8-c8ab423769dd	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208605 application number: ANDA208605
Telmisartan	TELMISARTAN	Modavar Pharmaceuticals LLC	a075633a-2a2a-4e88-8ede-b49a3920a16c	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208605 application number: ANDA208605 ndc (product): 72241-015
Telmisartan	TELMISARTAN	Cadila Pharmaceuticals Limited	353fcb30-2fa7-4ff1-8a18-26f3ec279d00	2023-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208605 application number: ANDA208605

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	e2deff49-b75e-4aaa-8114-d5ea1e3a94a5	100
282755	telmisartan 20 MG Oral Tablet	SCD	e2deff49-b75e-4aaa-8114-d5ea1e3a94a5	100
282755	telmisartan 20 MG Oral Tablet	PSN	a075633a-2a2a-4e88-8ede-b49a3920a16c	4
205304	telmisartan 40 MG Oral Tablet	PSN	a075633a-2a2a-4e88-8ede-b49a3920a16c	4
205305	telmisartan 80 MG Oral Tablet	PSN	a075633a-2a2a-4e88-8ede-b49a3920a16c	4
282755	telmisartan 20 MG Oral Tablet	SCD	a075633a-2a2a-4e88-8ede-b49a3920a16c	4
205304	telmisartan 40 MG Oral Tablet	SCD	a075633a-2a2a-4e88-8ede-b49a3920a16c	4
205305	telmisartan 80 MG Oral Tablet	SCD	a075633a-2a2a-4e88-8ede-b49a3920a16c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72241-015-04	72241001504	90 TABLET in 1 BOTTLE (72241-015-04)	90 tablet	2022-12-22		No	No	Current
72241-015-05	72241001505	100 TABLET in 1 BOTTLE (72241-015-05)	100 tablet	2022-12-22		No	No	Current
72241-015-10	72241001510	500 TABLET in 1 BOTTLE (72241-015-10)	500 tablet	2022-12-22		No	No	Current
72241-015-11	72241001511	1000 TABLET in 1 BOTTLE (72241-015-11)	1000 tablet	2022-12-22		No	No	Current
72241-015-16	72241001516	30 BLISTER PACK in 1 CARTON (72241-015-16) / 10 TABLET in 1 BLISTER PACK	30 blister pack	2015-02-05	0000-00-00	No	No	Current
72241-015-18	72241001518	30 BLISTER PACK in 1 CARTON (72241-015-18) / 10 TABLET in 1 BLISTER PACK	30 blister pack	2015-02-05	0000-00-00	No	No	Current
72241-015-22	72241001522	30 TABLET in 1 BOTTLE (72241-015-22)	30 tablet	2022-12-22		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan	Bryant Ranch Prepack	2024-12-23	HUMAN PRESCRIPTION DRUG LABEL	100
Telmisartan	Modavar Pharmaceuticals LLC \| Cadila Pharmaceuticals Limited	2023-09-30	Human Prescription Drug Label	4