telmisartan

Product NDC: 63629-5682
11-digit product format: 636295682
Labeler code: 63629
Product ID: 63629-5682_33603cf2-4536-8522-e063-6394a90a379f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205150
Marketing category: ANDA
Marketing start: 2016-06-12
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 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…`

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
44e810d4-cf04-41d3-bdf8-0681210a669f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-5682-1	telmisartan	30 in 1 BOTTLE	TABLET	30		104
63629-5682-2	telmisartan	90 in 1 BOTTLE	TABLET	90		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-5682-1	EA - Each	63629-5682	c2194b09-f5ee-4ce1-9c18-8611a469f94f	1	2025-01-14
63629-5682-2	EA - Each	63629-5682	fd2d1d06-f596-421e-a016-7a0a9844637f	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-5682	TELMISARTAN TABLET [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 2 package rows	20250424_44e810d4-cf04-41d3-bdf8-0681210a669f.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 ndc (product): 63629-5682
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
205304	telmisartan 40 MG Oral Tablet	PSN	44e810d4-cf04-41d3-bdf8-0681210a669f	104
205304	telmisartan 40 MG Oral Tablet	SCD	44e810d4-cf04-41d3-bdf8-0681210a669f	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-5682-1	63629568201	30 TABLET in 1 BOTTLE (63629-5682-1)	30 tablet	2021-01-14	0000-00-00	No	No	Current
63629-5682-2	63629568202	90 TABLET in 1 BOTTLE (63629-5682-2)	90 tablet	2023-03-09	0000-00-00	No	No	Current