Olmesartan Medoxomil

Product NDC: 57664-755
Requested package NDC: 57664-755-83
11-digit product format: 576640755
Labeler code: 57664
Product ID: 57664-755_bfbe03f6-a301-44ef-b01b-028dc18b679c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA021286
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-10-26
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57664-755	57664-755-83	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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	RLD / RS	Approval date
N021286-001	BENICAR	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	RLD	2002-04-25
N021286-003	BENICAR	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	RLD	2002-04-25
N021286-004	BENICAR	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021286-001	AB
N021286-003	AB
N021286-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021286-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57664-755-83	2020-08-04	C162847	48780-1	ab0e2407-31d8-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
57664-755-83	2020-07-22	C162847	48780-1	ab0e2407-31d8-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-755-83	EA - Each	57664-755	0e1f7442-22f8-475d-ad96-6f5d72596590	1	2016-11-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benicar	OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	dc3f1fd4-5578-4c5d-be7b-12e3f8f3e7df	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021286 application number: NDA021286
Benicar	OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	5b6f8a18-8f8a-4521-81c3-3a39c73c6646	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021286 application number: NDA021286

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-755-83	57664075583	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-755-83)	2016-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil	Sun Pharmaceutical Industries, Inc.	2021-11-23	HUMAN PRESCRIPTION DRUG LABEL	7