olmesartan medoxomil

Product NDC
71335-0817
Requested package NDC
71335-0817-3
11-digit product format
713350817
Labeler code
71335
Product ID
71335-0817_5984eb87-33f0-48db-aed8-fb2ea96c033b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207662
Marketing category
ANDA
Marketing start
2017-04-27
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
2026-12-31
Current FDA listing
Yes

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 packagepackage71335-081771335-0817-3DDiscontinued by firm2026-08-03

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 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 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
A207662-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24
A207662-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24
A207662-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207662-001AB
A207662-002AB
A207662-003AB

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 UTC2026-02A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207662-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-04-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207662-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207662-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207662-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207662-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207662-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207662-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207662-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207662-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207662-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207662-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207662-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207662-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207662-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207662-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207662-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207662-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207662-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
olmesartan medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M97XTV3HDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349405Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a021ffc-8b11-4ddf-81c4-87515971fdeeAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0817-1olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED30102
71335-0817-2olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED90102
71335-0817-3olmesartan medoxomil28 in 1 BOTTLETABLET, FILM COATED28102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0817OLMESARTAN MEDOXOMIL TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20240829_8a021ffc-8b11-4ddf-81c4-87515971fdee.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack79e2620d-6554-4e03-8087-59ec2e4dd75b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILAccord Healthcare Inc.e5dbca00-4e1b-4479-b829-021b11bc021e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rxe64c3b3b-d5e7-6d46-e053-2a95a90a1b642025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILdirect rxb57e47a5-43e0-d1c5-e053-2a95a90a2b072025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack8a021ffc-8b11-4ddf-81c4-87515971fdee2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
ndc (package): 71335-0817-3
ndc (product): 71335-0817
ndc11 (package): 71335081703
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepacka4ceea38-8fff-4317-be04-8dc22222ec702024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionsb55b6172-d986-4fd9-ba85-a8393c9089492023-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions949e6bad-fcb2-42f2-b9c8-e5620ef5ccd52023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions7afa79de-d42e-4429-874d-449d47a59fbe2023-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207662
application number: ANDA207662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN8a021ffc-8b11-4ddf-81c4-87515971fdee102
349405olmesartan medoxomil 40 MG Oral TabletSCD8a021ffc-8b11-4ddf-81c4-87515971fdee102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0817-37133508170328 TABLET, FILM COATED in 1 BOTTLE (71335-0817-3) 2022-02-090000-00-00NoNoCurrent