Olmesartan Medoxomil

Product NDC
50090-3107
11-digit product format
500903107
Labeler code
50090
Product ID
50090-3107_64715b8e-5558-41e6-9858-148f743483e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091079
Marketing category
ANDA
Marketing start
2017-04-24
Marketing end
0000-00-00
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
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3107IInactivated by FDA2026-08-03
excluded packagepackage50090-310750090-3107-0IInactivated by FDA2026-08-03
excluded packagepackage50090-310750090-3107-1IInactivated by FDA2026-08-03

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 2 · 63 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3107-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3107-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3107-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3107-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3107-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3107-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3107-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3107-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3107-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3107-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3107-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3107-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3107-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3107-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3107-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3107-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3107-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3107-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3107-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3107-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3107-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3107-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3107-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3107-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3107-08af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3107-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3107-0834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3107-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3107-01332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3107-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-3107-0fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-3107-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-3107-086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-3107-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-3107-0bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-3107-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-3107-08dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-3107-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-3107-0e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-3107-1e2bbac7714bc…27bdfed8d636…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091079-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24
A091079-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24
A091079-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091079-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091079-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091079-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-248072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091079-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091079-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091079-003AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A091079-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091079-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091079-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091079-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091079-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091079-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3107-0Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED303
50090-3107-1Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3107-0EA - Each50090-310749d76e5e-56ee-49eb-8317-e122663161ce12018-11-06
50090-3107-1EA - Each50090-3107d21addd4-42d9-43e3-b2e3-ad6a3520212012018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3107OLMESARTAN MEDOXOMIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20180813_5212e6e8-d3dd-4e92-8352-81b9a8c5cf47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN5212e6e8-d3dd-4e92-8352-81b9a8c5cf473
349401olmesartan medoxomil 20 MG Oral TabletSCD5212e6e8-d3dd-4e92-8352-81b9a8c5cf473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3107-05009031070030 in 1 BOTTLEHistorical
50090-3107-15009031070190 in 1 BOTTLEHistorical