Olmesartan Medoxomil

Product NDC: 72189-558
Requested package NDC: 72189-558-90
11-digit product format: 721890558
Labeler code: 72189
Product ID: 72189-558_2cc83fbd-3bda-a6e6-e063-6294a90a95a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET
Route: ORAL
Labeler: Direct_rx
Application: ANDA206720
Marketing category: ANDA
Marketing start: 2024-06-24
Substance: OLMESARTAN MEDOXOMIL
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

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	TE codes	Approval date
A206720-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02
A206720-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02
A206720-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206720-001	AB
A206720-002	AB
A206720-003	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 2 · 78 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	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206720-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2022-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206720-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2022-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206720-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2022-12-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206720-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206720-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206720-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206720-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206720-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206720-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206720-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206720-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206720-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206720-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206720-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206720-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206720-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206720-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206720-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206720-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206720-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206720-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206720-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206720-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206720-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206720-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206720-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206720-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206720-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206720-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206720-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206720-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206720-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206720-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206720-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206720-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206720-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206720-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206720-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206720-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206720-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206720-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206720-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206720-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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	20 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
349401	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
1ba299e7-0651-c23b-e063-6294a90a0245	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-558-30	Olmesartan Medoxomil	30 in 1 BOTTLE	TABLET	30		2
72189-558-90	Olmesartan Medoxomil	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-558-30	EA - Each	72189-558	bc6c7496-95d3-4f64-a62e-7cd697f1a2b5	1	2025-03-04
72189-558-90	EA - Each	72189-558	1c01372e-6a1d-479e-bb31-fd25a1068aa5	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-558	OLMESARTAN MEDOXOMIL TABLET [DIRECT_RX]	2	Current NDC, 2 package rows	20250130_1ba299e7-0651-c23b-e063-6294a90a0245.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	4bf142a3-ad7f-4ed5-98c2-54d8509b7dbc	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206720 application number: ANDA206720
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb3	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206720 application number: ANDA206720
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	2bb63404-7d54-4482-8377-6ff02052892a	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206720 application number: ANDA206720
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_rx	1ba299e7-0651-c23b-e063-6294a90a0245	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206720 application number: ANDA206720 ndc (package): 72189-558-90 ndc (product): 72189-558 ndc11 (package): 72189055890
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	879630ff-662a-40bd-b74f-a864661dea95	2024-06-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206720 application number: ANDA206720
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Solco Healthcare US, LLC.	6e602f81-1cc3-4ae1-8bdf-85572e35cf73	2022-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206720 application number: ANDA206720

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	1ba299e7-0651-c23b-e063-6294a90a0245	2
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	1ba299e7-0651-c23b-e063-6294a90a0245	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-558-90	72189055890	90 TABLET in 1 BOTTLE (72189-558-90)	90 tablet	2024-06-24	No	No	Current