Olmesartan Medoxomil

Product NDC
50090-6686
11-digit product format
500906686
Labeler code
50090
Product ID
50090-6686_3f7f4a93-5c49-487b-9fde-43cfb92a1c34
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
20 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 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
A203281-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25
A203281-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25
A203281-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203281-001AB
A203281-002AB
A203281-003AB

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 UTC2026-02A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203281-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2017-05-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203281-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2017-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203281-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2017-05-258072bd15b7f6…

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 UTC2026-02A203281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203281-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203281-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203281-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203281-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203281-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203281-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203281-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203281-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203281-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203281-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203281-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203281-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203281-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203281-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203281-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203281-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203281-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203281-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203281-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203281-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203281-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203281-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203281-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203281-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203281-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203281-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203281-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203281-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203281-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203281-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203281-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203281-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203281-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203281-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203281-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203281-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203281-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203281-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203281-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 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
349401Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5972c6fd-08e3-4189-a894-1ba220b57e80Available 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
50090-6686-0Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6686OLMESARTAN MEDOXOMIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230922_5972c6fd-08e3-4189-a894-1ba220b57e80.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions5972c6fd-08e3-4189-a894-1ba220b57e802026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203281
application number: ANDA203281
ndc (product): 50090-6686
Olmesartan MedoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack57dc737b-01e2-4b22-991f-d4710950dcf32026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203281
application number: ANDA203281
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions67aa498d-edf6-45b8-a3fd-019c3fb769602026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203281
application number: ANDA203281
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions8acdc142-aa38-4fcb-bd15-fbba9635a4c62026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203281
application number: ANDA203281
Olmesartan MedoxomilOLMESARTAN MEDOXOMILGlenmark Pharmaceuticals Inc., USA8e0adf3d-7569-4909-bab1-5fed9578ad772026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203281
application number: ANDA203281

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN5972c6fd-08e3-4189-a894-1ba220b57e803
349401olmesartan medoxomil 20 MG Oral TabletSCD5972c6fd-08e3-4189-a894-1ba220b57e803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6686-05009066860090 TABLET, FILM COATED in 1 BOTTLE (50090-6686-0) 2023-09-15NoNoCurrent