OLMESARTAN MEDOXOMIL

Product NDC: 42571-201
11-digit product format: 425710201
Labeler code: 42571
Product ID: 42571-201_d1aee355-45f4-1ff5-e053-2a95a90a9d2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA206372
Marketing category: ANDA
Marketing start: 2020-02-03
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42571-201		D	Discontinued by firm	2026-10-12
excluded package	package	42571-201	42571-201-05	D	Discontinued by firm	2026-10-12
excluded package	package	42571-201	42571-201-10	D	Discontinued by firm	2026-10-12
excluded package	package	42571-201	42571-201-11	D	Discontinued by firm	2026-10-12
excluded package	package	42571-201	42571-201-30	D	Discontinued by firm	2026-10-12
excluded package	package	42571-201	42571-201-90	D	Discontinued by firm	2026-10-12

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	Approval date
A206372-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2019-09-17
A206372-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2019-09-17
A206372-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2019-09-17

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
2026-09-14 22:38:34	2026-08	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2019-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL		2019-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL		2019-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206372-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206372-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206372-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-09-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206372-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206372-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206372-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206372-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206372-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206372-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206372-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206372-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206372-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206372-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206372-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206372-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206372-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206372-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206372-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206372-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206372-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206372-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206372-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206372-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206372-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206372-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206372-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206372-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206372-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206372-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206372-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206372-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206372-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206372-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206372-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206372-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206372-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206372-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206372-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206372-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206372-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206372-003	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206372-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206372-002	AB	1	`6a51e52b5d6a…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
42571-201-05	OLMESARTAN MEDOXOMIL	500 in 1 BOTTLE	TABLET, FILM COATED	500	7
42571-201-10	OLMESARTAN MEDOXOMIL	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	7
42571-201-11	OLMESARTAN MEDOXOMIL	10 in 1 CARTON	TABLET, FILM COATED	10	7
42571-201-30	OLMESARTAN MEDOXOMIL	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
42571-201-32	OLMESARTAN MEDOXOMIL	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	7
42571-201-90	OLMESARTAN MEDOXOMIL	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-201-30	EA - Each	42571-201	318381c2-782f-4ce1-b5b0-1e93d0b43e8b	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-201	OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MICRO LABS LIMITED]	7	Legacy NDC, 6 package rows	20250529_de799a31-50ae-4b9e-a159-3d399b523dca.zip

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	de799a31-50ae-4b9e-a159-3d399b523dca	7
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	de799a31-50ae-4b9e-a159-3d399b523dca	7
349373	olmesartan medoxomil 5 MG Oral Tablet	PSN	de799a31-50ae-4b9e-a159-3d399b523dca	7
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	de799a31-50ae-4b9e-a159-3d399b523dca	7
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	de799a31-50ae-4b9e-a159-3d399b523dca	7
349373	olmesartan medoxomil 5 MG Oral Tablet	SCD	de799a31-50ae-4b9e-a159-3d399b523dca	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-201-05	42571020105	500 TABLET, FILM COATED in 1 BOTTLE (42571-201-05)		2020-02-03	0000-00-00	No	No	Current
42571-201-10	42571020110	1000 TABLET, FILM COATED in 1 BOTTLE (42571-201-10)		2020-02-03	0000-00-00	No	No	Current
42571-201-11	42571020111	10 BLISTER PACK in 1 CARTON (42571-201-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-201-32)	10 blister pack	2020-02-03	0000-00-00	No	No	Current
42571-201-30	42571020130	30 TABLET, FILM COATED in 1 BOTTLE (42571-201-30)		2020-02-03	0000-00-00	No	No	Current
42571-201-32	42571020132	10 in 1 BLISTER PACK						Historical
42571-201-90	42571020190	90 TABLET, FILM COATED in 1 BOTTLE (42571-201-90)		2020-02-03	0000-00-00	No	No	Current