Telmisartan

Product NDC: 43547-285
11-digit product format: 435470285
Labeler code: 43547
Product ID: 43547-285_98f95e17-f88b-4f47-b4bb-5db8f93793f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA207882
Marketing category: ANDA
Marketing start: 2017-08-20
Substance: TELMISARTAN
Active strength: 80 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A207882-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03
A207882-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03
A207882-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207882-001	AB
A207882-002	AB
A207882-003	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	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207882-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2017-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207882-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2017-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207882-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2017-05-03	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A207882-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207882-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207882-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207882-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207882-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207882-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207882-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207882-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207882-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207882-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207882-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207882-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207882-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207882-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207882-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207882-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207882-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207882-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207882-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207882-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Telmisartan
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	80 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
77442f0b-b522-4b19-ac1f-f0ce8576f0be	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	SPL version
43547-285-03	Telmisartan	30 in 1 BOTTLE	TABLET	30	11
43547-285-09	Telmisartan	90 in 1 BOTTLE	TABLET	90	11
43547-285-50	Telmisartan	500 in 1 BOTTLE	TABLET	500	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-285-03	EA - Each	43547-285	b5214ec9-3437-433f-8e1b-f542558423af	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-285	TELMISARTAN TABLET TELMISARTAN TABLET [SOLCO HEALTHCARE US, LLC]	9	Current NDC, Legacy NDC, 3 package rows	20230710_77442f0b-b522-4b19-ac1f-f0ce8576f0be.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	REMEDYREPACK INC.	57da6ef2-2e86-4e4d-90df-73a2a8cf97f6	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207882 application number: ANDA207882
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	830741dd-3f3c-4f8e-88c6-dc112166f477	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207882 application number: ANDA207882
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	a5ded796-3555-4476-8b37-0cdc88d7594a	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207882 application number: ANDA207882
Telmisartan	TELMISARTAN	Solco Healthcare US, LLC	77442f0b-b522-4b19-ac1f-f0ce8576f0be	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207882 application number: ANDA207882 ndc (product): 43547-285
Telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	d45da80a-58c3-4461-adf6-a85531c09eb8	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207882 application number: ANDA207882
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals, Inc.	3f021f06-99df-48d1-e063-6394a90a8d0f	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207882 application number: ANDA207882

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
205305	telmisartan 80 MG Oral Tablet	PSN	830741dd-3f3c-4f8e-88c6-dc112166f477	102
205305	telmisartan 80 MG Oral Tablet	SCD	830741dd-3f3c-4f8e-88c6-dc112166f477	102
282755	telmisartan 20 MG Oral Tablet	PSN	77442f0b-b522-4b19-ac1f-f0ce8576f0be	11
205304	telmisartan 40 MG Oral Tablet	PSN	77442f0b-b522-4b19-ac1f-f0ce8576f0be	11
205305	telmisartan 80 MG Oral Tablet	PSN	77442f0b-b522-4b19-ac1f-f0ce8576f0be	11
282755	telmisartan 20 MG Oral Tablet	SCD	77442f0b-b522-4b19-ac1f-f0ce8576f0be	11
205304	telmisartan 40 MG Oral Tablet	SCD	77442f0b-b522-4b19-ac1f-f0ce8576f0be	11
205305	telmisartan 80 MG Oral Tablet	SCD	77442f0b-b522-4b19-ac1f-f0ce8576f0be	11
205305	telmisartan 80 MG Oral Tablet	PSN	57da6ef2-2e86-4e4d-90df-73a2a8cf97f6	7
205305	telmisartan 80 MG Oral Tablet	SCD	57da6ef2-2e86-4e4d-90df-73a2a8cf97f6	7
205305	telmisartan 80 MG Oral Tablet	PSN	3f021f06-99df-48d1-e063-6394a90a8d0f	1
205305	telmisartan 80 MG Oral Tablet	SCD	3f021f06-99df-48d1-e063-6394a90a8d0f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-285-03	43547028503	30 TABLET in 1 BOTTLE (43547-285-03)	30 tablet	2017-08-20	0000-00-00	No	No	Current
43547-285-09	43547028509	90 TABLET in 1 BOTTLE (43547-285-09)	90 tablet	2017-08-20	0000-00-00	No	No	Current
43547-285-50	43547028550	500 TABLET in 1 BOTTLE (43547-285-50)	500 tablet	2017-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan	REMEDYREPACK INC.	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	8
Telmisartan	Bryant Ranch Prepack	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	102
Telmisartan	Solco Healthcare US, LLC \| Prinston Pharmaceutical, Inc. \| Zhejiang Huahai Pharmaceutical Co.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	11
Telmisartan	NuCare Pharmaceuticals, Inc.	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	1