OLMESARTAN MEDOXOMIL

Product NDC
68180-725
Requested package NDC
68180-725-06
11-digit product format
681800725
Labeler code
68180
Product ID
68180-725_8dfa49ab-de71-477e-b98e-17e76eebecec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA206631
Marketing category
ANDA
Marketing start
2017-09-01
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68180-72568180-725-06DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206631-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27
A206631-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27
A206631-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2784e616aacf4f…
2026-09-14 22:38:342026-08A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2784e616aacf4f…
2026-09-14 22:38:342026-08A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2784e616aacf4f…
2026-08-18 06:07:402026-07A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206631-002OLMESARTAN MEDOXOMIL20MGTABLET / ORAL2017-04-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206631-003OLMESARTAN MEDOXOMIL40MGTABLET / ORAL2017-04-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206631-001OLMESARTAN MEDOXOMIL5MGTABLET / ORAL2017-04-27301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A206631-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206631-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206631-003AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206631-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206631-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206631-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206631-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206631-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206631-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206631-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206631-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206631-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206631-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206631-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206631-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206631-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206631-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206631-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206631-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206631-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206631-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206631-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206631-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206631-003AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68180-725-062023-10-04These 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
68180-725-092023-10-04These 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
68180-725-172023-10-04These 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
68180-725-062023-01-30These 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
68180-725-092023-01-30These 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
68180-725-172023-01-30These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-725-06EA - Each68180-725e3b890e7-80df-47ad-bf39-f79933a7d05212017-09-11
68180-725-09EA - Each68180-725f2074186-d0b3-4603-9f6d-663c4ef73bbb12017-09-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-725-066818007250630 TABLET, FILM COATED in 1 BOTTLE (68180-725-06) 2017-09-010000-00-00NoNoCurrent