Olmesartan Medoxomil

Product NDC: 50090-4451
Requested package NDC: 50090-4451-1
11-digit product format: 500904451
Labeler code: 50090
Product ID: 50090-4451_65f41aa8-81da-4c9d-a51d-56f811bd91a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA203281
Marketing category: ANDA
Marketing start: 2017-05-25
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

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A203281-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25
A203281-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25
A203281-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203281-001	AB
A203281-002	AB
A203281-003	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	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`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	A203281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203281-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
67aa498d-edf6-45b8-a3fd-019c3fb76960	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4451-0	2023-01-30	C162847	48780-1	f386c64a-17f8-0266-e053-dadaa90a7c1a	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
50090-4451-1	2023-01-30	C162847	48780-1	f386c64a-17f8-0266-e053-dadaa90a7c1a	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4451-0	Olmesartan Medoxomil	30 in 1 BOTTLE	TABLET, FILM COATED	30		7
50090-4451-1	Olmesartan Medoxomil	90 in 1 BOTTLE	TABLET, FILM COATED	90		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4451	OLMESARTAN MEDOXOMIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	5	Current NDC, Legacy NDC, 2 package rows	20210417_67aa498d-edf6-45b8-a3fd-019c3fb76960.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 · 5 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	5972c6fd-08e3-4189-a894-1ba220b57e80	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	57dc737b-01e2-4b22-991f-d4710950dcf3	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	67aa498d-edf6-45b8-a3fd-019c3fb76960	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281 ndc (package): 50090-4451-1 ndc (product): 50090-4451 ndc11 (package): 50090445101
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	8acdc142-aa38-4fcb-bd15-fbba9635a4c6	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Glenmark Pharmaceuticals Inc., USA	8e0adf3d-7569-4909-bab1-5fed9578ad77	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281

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
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	67aa498d-edf6-45b8-a3fd-019c3fb76960	7
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	67aa498d-edf6-45b8-a3fd-019c3fb76960	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4451-1	50090445101	90 TABLET, FILM COATED in 1 BOTTLE (50090-4451-1)	2019-08-05	0000-00-00	No	No	Current