Telmisartan

Product NDC: 59746-439
11-digit product format: 597460439
Labeler code: 59746
Product ID: 59746-439_482ba8bc-d601-48d8-9d50-8fa4d2c255fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan
Dosage form: TABLET
Route: ORAL
Labeler: Jubilant Cadista Pharmacuticals Inc.
Application: ANDA204164
Marketing category: ANDA
Marketing start: 2016-08-22
Substance: TELMISARTAN
Active strength: 20 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-439-32	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-439-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-439-32	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-439-32	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A204164-001	TELMISARTAN	TELMISARTAN	20MG	TABLET / ORAL	AB	2016-08-22
A204164-002	TELMISARTAN	TELMISARTAN	40MG	TABLET / ORAL	AB	2016-08-22
A204164-003	TELMISARTAN	TELMISARTAN	80MG	TABLET / ORAL	AB	2016-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204164-001	AB
A204164-002	AB
A204164-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204164-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2016-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204164-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2016-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204164-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2016-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204164-001	TELMISARTAN	20MG	TABLET / ORAL	AB	2016-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204164-002	TELMISARTAN	40MG	TABLET / ORAL	AB	2016-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204164-003	TELMISARTAN	80MG	TABLET / ORAL	AB	2016-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204164-002	TELMISARTAN	40MG	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204164-003	TELMISARTAN	80MG	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204164-001	TELMISARTAN	20MG	TABLET / ORAL		2016-08-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204164-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204164-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204164-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204164-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204164-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204164-003	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A204164-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204164-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204164-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204164-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204164-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204164-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204164-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204164-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204164-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204164-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204164-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204164-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204164-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204164-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204164-003	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	20 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
e1a907a7-fad9-a860-8639-4c6136c85734	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
59746-439-12	Telmisartan	10 in 1 BLISTER PACK	TABLET	10		4
59746-439-32	Telmisartan	3 in 1 CARTON	TABLET	3		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-439-12	EA - Each	59746-439	def88b43-034a-490c-81b2-f52ede87303f	1	2017-12-14
59746-439-32	EA - Each	59746-439	3af4ac24-b822-4c0b-9fae-a8ac4b23184b	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-439	TELMISARTAN TABLET [JUBILANT CADISTA PHARMACUTICALS INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250117_e1a907a7-fad9-a860-8639-4c6136c85734.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	Jubilant Cadista Pharmacuticals Inc.	e1a907a7-fad9-a860-8639-4c6136c85734	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204164 application number: ANDA204164 ndc (product): 59746-439

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	e1a907a7-fad9-a860-8639-4c6136c85734	4
205304	telmisartan 40 MG Oral Tablet	PSN	e1a907a7-fad9-a860-8639-4c6136c85734	4
205305	telmisartan 80 MG Oral Tablet	PSN	e1a907a7-fad9-a860-8639-4c6136c85734	4
282755	telmisartan 20 MG Oral Tablet	SCD	e1a907a7-fad9-a860-8639-4c6136c85734	4
205304	telmisartan 40 MG Oral Tablet	SCD	e1a907a7-fad9-a860-8639-4c6136c85734	4
205305	telmisartan 80 MG Oral Tablet	SCD	e1a907a7-fad9-a860-8639-4c6136c85734	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59746-439-12	59746043912	10 in 1 BLISTER PACK					Historical
59746-439-32	59746043932	3 BLISTER PACK in 1 CARTON (59746-439-32) / 10 TABLET in 1 BLISTER PACK (59746-439-12)	3 blister pack	2016-08-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Generics Limited	2025-01-15	Human Prescription Drug Label	4