OLMESARTAN MEDOXOMIL

Product NDC: 49252-067
Requested package NDC: 49252-067-10
11-digit product format: 492520067
Labeler code: 49252
Product ID: 49252-067_f29310d1-7b00-4057-9dd1-d9a69f542d5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OLMESARTAN MEDOXOMIL
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Inventia Healthcare Limited
Application: ANDA208659
Marketing category: ANDA
Marketing start: 2020-05-29
Substance: OLMESARTAN MEDOXOMIL
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A208659-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18
A208659-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18
A208659-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208659-001	AB
A208659-002	AB
A208659-003	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 3 · 117 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	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 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	A208659-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208659-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208659-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208659-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208659-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208659-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-001	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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	40 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
05a807bf-5175-43a2-a676-215bba2645a8	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
49252-067-10	OLMESARTAN MEDOXOMIL	30 in 1 BOTTLE	TABLET, COATED	30	3
49252-067-12	OLMESARTAN MEDOXOMIL	90 in 1 BOTTLE	TABLET, COATED	90	3
49252-067-18	OLMESARTAN MEDOXOMIL	1000 in 1 BOTTLE	TABLET, COATED	1000	3
49252-067-57	OLMESARTAN MEDOXOMIL	10 in 1 CARTON	TABLET, COATED	10	3
49252-067-57	OLMESARTAN MEDOXOMIL	10 in 1 BLISTER PACK	TABLET, COATED	10	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49252-067	OLMESARTAN MEDOXOMIL TABLET, COATED OLMESARTAN MEDOXOMIL TABLET, COATED [INVENTIA HEALTHCARE LIMITED]	3	Current NDC, Legacy NDC, 5 package rows	20230919_05a807bf-5175-43a2-a676-215bba2645a8.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 · 3 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	1df1ff60-6be5-4018-a28c-0d23e5867eba	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208659 application number: ANDA208659
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Rising Pharma Holdings, Inc.	b02ff20e-3f0e-43f4-a7b5-6ce56295d023	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208659 application number: ANDA208659
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Inventia Healthcare Limited	05a807bf-5175-43a2-a676-215bba2645a8	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208659 application number: ANDA208659 ndc (package): 49252-067-10 ndc (product): 49252-067 ndc11 (package): 49252006710

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	05a807bf-5175-43a2-a676-215bba2645a8	3
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	05a807bf-5175-43a2-a676-215bba2645a8	3
349373	olmesartan medoxomil 5 MG Oral Tablet	PSN	05a807bf-5175-43a2-a676-215bba2645a8	3
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	05a807bf-5175-43a2-a676-215bba2645a8	3
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	05a807bf-5175-43a2-a676-215bba2645a8	3
349373	olmesartan medoxomil 5 MG Oral Tablet	SCD	05a807bf-5175-43a2-a676-215bba2645a8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49252-067-10	49252006710	30 TABLET, COATED in 1 BOTTLE (49252-067-10)	2020-05-29	0000-00-00	No	No	Current