Olmesartan Medoxomil

Product NDC: 72189-373
11-digit product format: 721890373
Labeler code: 72189
Product ID: 72189-373_2c4cb2f6-84b2-31c2-e063-6394a90a5568
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA207662
Marketing category: ANDA
Marketing start: 2022-08-15
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 · 4 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
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-373-90	`ed331223b511…`	`672a5bd82f5f…`
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	72189-373-90	`0efc9e666f02…`	`f202fb6c5f17…`

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
A207662-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24
A207662-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24
A207662-003	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
A207662-001	AB
A207662-002	AB
A207662-003	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	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`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	A207662-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207662-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207662-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207662-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349373	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
e64c3b3b-d5e7-6d46-e053-2a95a90a1b64	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	Strength	SPL version
72189-373-90	Olmesartan Medoxomil	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-373-90	EA - Each	72189-373	6d7a491f-5edd-49ea-9aed-cd1cc5bc6fe5	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-373	OLMESARTAN MEDOXOMIL TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20250123_e64c3b3b-d5e7-6d46-e053-2a95a90a1b64.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	79e2620d-6554-4e03-8087-59ec2e4dd75b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Accord Healthcare Inc.	e5dbca00-4e1b-4479-b829-021b11bc021e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	e64c3b3b-d5e7-6d46-e053-2a95a90a1b64	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 72189-373
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	direct rx	b57e47a5-43e0-d1c5-e053-2a95a90a2b07	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	8a021ffc-8b11-4ddf-81c4-87515971fdee	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	a4ceea38-8fff-4317-be04-8dc22222ec70	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	b55b6172-d986-4fd9-ba85-a8393c908949	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	949e6bad-fcb2-42f2-b9c8-e5620ef5ccd5	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	7afa79de-d42e-4429-874d-449d47a59fbe	2023-05-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662

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
349373	olmesartan medoxomil 5 MG Oral Tablet	PSN	e64c3b3b-d5e7-6d46-e053-2a95a90a1b64	2
349373	olmesartan medoxomil 5 MG Oral Tablet	SCD	e64c3b3b-d5e7-6d46-e053-2a95a90a1b64	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-373-90	72189037390	90 TABLET, FILM COATED in 1 BOTTLE (72189-373-90)	2022-08-15	0000-00-00	No	No	Current