Telmisartan

Product NDC: 33342-119
Requested package NDC: 33342-119-07
11-digit product format: 333420119
Labeler code: 33342
Product ID: 33342-119_94abae59-69ec-482d-b4cf-285d502d82e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA203986
Marketing category: ANDA
Marketing start: 2025-01-15
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
A203986-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15
A203986-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15
A203986-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203986-001	AB
A203986-002	AB
A203986-003	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.

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	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203986-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2025-01-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203986-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2025-01-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203986-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2025-01-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203986-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203986-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203986-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203986-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203986-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203986-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203986-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203986-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203986-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203986-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203986-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203986-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203986-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203986-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203986-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203986-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203986-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203986-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203986-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203986-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203986-003	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203986-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203986-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203986-003	AB	1	`a50c72e98297…`

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
671d5a85-4146-43b4-9d7d-ca53268eb2a6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
33342-119-07	Telmisartan	30 in 1 CONTAINER	TABLET	30		2
33342-119-10	Telmisartan	90 in 1 CONTAINER	TABLET	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-119	TELMISARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]	1	Current NDC, 2 package rows	20250406_671d5a85-4146-43b4-9d7d-ca53268eb2a6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	Redpharm Drug	5743c58e-deab-ac93-e063-6294a90ac1eb	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203986 application number: ANDA203986
Telmisartan	TELMISARTAN	Macleods Pharmaceuticals Limited	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203986 application number: ANDA203986 ndc (package): 33342-119-07 ndc (product): 33342-119 ndc11 (package): 33342011907
Telmisartan	TELMISARTAN	NorthStar RxLLC	9c22a318-d1f2-4788-9331-66fed71ebf38	2025-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203986 application number: ANDA203986

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	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2
205304	telmisartan 40 MG Oral Tablet	PSN	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2
205305	telmisartan 80 MG Oral Tablet	PSN	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2
282755	telmisartan 20 MG Oral Tablet	SCD	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2
205304	telmisartan 40 MG Oral Tablet	SCD	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2
205305	telmisartan 80 MG Oral Tablet	SCD	671d5a85-4146-43b4-9d7d-ca53268eb2a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
33342-119-07	33342011907	30 TABLET in 1 CONTAINER (33342-119-07)	30 tablet	2025-01-15	No	No	Current