Telmisartan

Product NDC: 68462-200
11-digit product format: 684620200
Labeler code: 68462
Product ID: 68462-200_7e08eda5-be87-4e09-ae4e-880a18aa7a0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA090032
Marketing category: ANDA
Marketing start: 2014-07-07
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: 2027-12-31
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
A090032-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07
A090032-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07
A090032-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090032-001	AB
A090032-002	AB
A090032-003	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	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090032-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090032-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2014-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090032-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2014-07-07	`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	A090032-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090032-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090032-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090032-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090032-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090032-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090032-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090032-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090032-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090032-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090032-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090032-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090032-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090032-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090032-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090032-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090032-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090032-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090032-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090032-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090032-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090032-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090032-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090032-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090032-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090032-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090032-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090032-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090032-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090032-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090032-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090032-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090032-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090032-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090032-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090032-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090032-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090032-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090032-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090032-001	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: 2027-12-31

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 · 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
c6eb489d-2946-4c14-839f-d4af761ead31	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
68462-200-01	Telmisartan	100 in 1 BOTTLE	TABLET	100	12
68462-200-13	Telmisartan	3 in 1 CARTON	TABLET	3	12
68462-200-13	Telmisartan	10 in 1 BLISTER PACK	TABLET	10	12
68462-200-30	Telmisartan	30 in 1 BOTTLE	TABLET	30	12
68462-200-82	Telmisartan	10 in 1 BLISTER PACK	TABLET	10	12
68462-200-82	Telmisartan	5 in 1 CARTON	TABLET	5	12
68462-200-90	Telmisartan	90 in 1 BOTTLE	TABLET	90	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-200-13	EA - Each	68462-200	6652b4b1-03a2-4202-9eaa-dd48369d5538	1	2014-08-01
68462-200-30	EA - Each	68462-200	44365b3d-6aa9-4d43-ae3b-7379472dfd25	1	2021-04-08
68462-200-90	EA - Each	68462-200	505cf5c9-3e04-48a7-8fa3-b941b896530c	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-200	TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	11	Current NDC, Legacy NDC, 7 package rows	20240315_c6eb489d-2946-4c14-839f-d4af761ead31.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	REMEDYREPACK INC.	91215664-6e19-4e04-9ae7-ab5664799426	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090032 application number: ANDA090032
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	c55e4fe1-f04d-4995-a706-9f432fde57e4	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090032 application number: ANDA090032
Telmisartan	TELMISARTAN	Glenmark Pharmaceuticals Inc., USA	c6eb489d-2946-4c14-839f-d4af761ead31	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090032 application number: ANDA090032 ndc (product): 68462-200
Telmisartan	TELMISARTAN	Preferred Pharmaceuticals Inc.	bf8e95fa-d181-4b46-8609-497e14a73dc1	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090032 application number: ANDA090032
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals,Inc.	a020e2a7-d1e7-8ae0-e053-2995a90abad3	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090032 application number: ANDA090032

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	c6eb489d-2946-4c14-839f-d4af761ead31	12
205304	telmisartan 40 MG Oral Tablet	PSN	c6eb489d-2946-4c14-839f-d4af761ead31	12
205305	telmisartan 80 MG Oral Tablet	PSN	c6eb489d-2946-4c14-839f-d4af761ead31	12
282755	telmisartan 20 MG Oral Tablet	SCD	c6eb489d-2946-4c14-839f-d4af761ead31	12
205304	telmisartan 40 MG Oral Tablet	SCD	c6eb489d-2946-4c14-839f-d4af761ead31	12
205305	telmisartan 80 MG Oral Tablet	SCD	c6eb489d-2946-4c14-839f-d4af761ead31	12
205304	telmisartan 40 MG Oral Tablet	PSN	bf8e95fa-d181-4b46-8609-497e14a73dc1	1
205304	telmisartan 40 MG Oral Tablet	SCD	bf8e95fa-d181-4b46-8609-497e14a73dc1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-200-01	68462020001	100 TABLET in 1 BOTTLE (68462-200-01)	100 tablet	2014-07-07	0000-00-00	No	No	Current
68462-200-13	68462020013	3 BLISTER PACK in 1 CARTON (68462-200-13) / 10 TABLET in 1 BLISTER PACK	3 blister pack	2014-07-07	0000-00-00	No	No	Current
68462-200-30	68462020030	30 TABLET in 1 BOTTLE (68462-200-30)	30 tablet	2020-12-14	0000-00-00	No	No	Current
68462-200-82	68462020082	5 BLISTER PACK in 1 CARTON (68462-200-82) / 10 TABLET in 1 BLISTER PACK	5 blister pack	2020-12-14	0000-00-00	No	No	Current
68462-200-90	68462020090	90 TABLET in 1 BOTTLE (68462-200-90)	90 tablet	2024-03-07		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	12
Telmisartan	Preferred Pharmaceuticals Inc.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	1