olmesartan medoxomil

Product NDC: 59746-463
11-digit product format: 597460463
Labeler code: 59746
Product ID: 59746-463_09a95078-de95-4c58-a910-4cd3b6f04810
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Jubilant Cadista Pharmacuticals Inc.
Application: ANDA205482
Marketing category: ANDA
Marketing start: 2016-04-01
Substance: OLMESARTAN MEDOXOMIL
Active strength: 5 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 · 20 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	59746-463-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-463-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-463-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59746-463-10	`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	59746-463-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-463-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-463-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59746-463-10	`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	59746-463-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-463-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-463-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59746-463-10	`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	59746-463-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-463-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-463-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59746-463-10	`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
A205482-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24
A205482-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24
A205482-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205482-001	AB
A205482-002	AB
A205482-003	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	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205482-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205482-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2017-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205482-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2017-04-24	`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	A205482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205482-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205482-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205482-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205482-003	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A205482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205482-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205482-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205482-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205482-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205482-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205482-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205482-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205482-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205482-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205482-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205482-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205482-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205482-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205482-003	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M97XTV3HD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349373	Internal RxNorm lookup
349401	Internal RxNorm lookup
349405	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
d5658d8a-f8e9-454d-89a9-34884e753001	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59746-463-01	olmesartan medoxomil	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	6
59746-463-10	olmesartan medoxomil	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	6
59746-463-30	olmesartan medoxomil	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	6
59746-463-32	olmesartan medoxomil	3 in 1 CARTON	TABLET, FILM COATED	3	6
59746-463-32	olmesartan medoxomil	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-463-30	EA - Each	59746-463	9d16a716-6b72-48f5-9b05-e524fac1240d	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-463	OLMESARTAN MEDOXOMIL TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.]	6	Current NDC, Legacy NDC, 5 package rows	20250326_d5658d8a-f8e9-454d-89a9-34884e753001.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
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Jubilant Cadista Pharmacuticals Inc.	d5658d8a-f8e9-454d-89a9-34884e753001	2025-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205482 application number: ANDA205482 ndc (product): 59746-463

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349401	olmesartan medoxomil 20 MG Oral Tablet	PSN	d5658d8a-f8e9-454d-89a9-34884e753001	6
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	d5658d8a-f8e9-454d-89a9-34884e753001	6
349373	olmesartan medoxomil 5 MG Oral Tablet	PSN	d5658d8a-f8e9-454d-89a9-34884e753001	6
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	d5658d8a-f8e9-454d-89a9-34884e753001	6
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	d5658d8a-f8e9-454d-89a9-34884e753001	6
349373	olmesartan medoxomil 5 MG Oral Tablet	SCD	d5658d8a-f8e9-454d-89a9-34884e753001	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59746-463-01	59746046301	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-01)		2017-04-24	No	No	Current
59746-463-10	59746046310	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-10)		2017-04-24	No	No	Current
59746-463-30	59746046330	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-30)		2017-04-24	No	No	Current
59746-463-32	59746046332	3 BLISTER PACK in 1 CARTON (59746-463-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2017-04-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
olmesartan medoxomil	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Generics Limited \| The ACME Laboratories Ltd	2025-03-23	Human Prescription Drug Label	6