Telmisartan

Product NDC: 72162-2439
11-digit product format: 721622439
Labeler code: 72162
Product ID: 72162-2439_3c89abda-3af1-4c1a-b454-b67257957be5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA208605
Marketing category: ANDA
Marketing start: 2015-02-05
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208605-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208605-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208605-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-07-25	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208605-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208605-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208605-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208605-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208605-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208605-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	40 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205304	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
b4ae8694-2af4-4acb-8634-b40c1cb6fb41	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	Strength	SPL version
72162-2439-3	Telmisartan	30 in 1 BOTTLE	TABLET	30		100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2439	TELMISARTAN TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 1 package rows	20241225_b4ae8694-2af4-4acb-8634-b40c1cb6fb41.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 ndc (product): 72162-2439
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
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
205304	telmisartan 40 MG Oral Tablet	PSN	b4ae8694-2af4-4acb-8634-b40c1cb6fb41	100
205304	telmisartan 40 MG Oral Tablet	SCD	b4ae8694-2af4-4acb-8634-b40c1cb6fb41	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2439-3	72162243903	30 TABLET in 1 BOTTLE (72162-2439-3)	30 tablet	2024-12-23	No	No	Current