olmesartan medoxomil

Product NDC
60505-4654
11-digit product format
605054654
Labeler code
60505
Product ID
60505-4654_ddf48401-f0f4-87ac-f6c6-da7d9d555a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA203281
Marketing category
ANDA
Marketing start
2018-08-23
Marketing end
0000-00-00
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
2020-12-31
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 productproduct60505-4654DDiscontinued by firm2026-08-03
excluded packagepackage60505-465460505-4654-3DDiscontinued by firm2026-08-03
excluded packagepackage60505-465460505-4654-9DDiscontinued 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 · 36 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 packagepackage60505-4654-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60505-4654-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-4654-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-4654-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-4654-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-4654-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-4654-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-4654-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-4654-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-4654-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-4654-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-4654-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-4654-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-4654-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-4654-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-4654-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-4654-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-4654-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-4654-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-4654-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-4654-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-4654-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-4654-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-4654-3557ba5c1ecfa…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
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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4654-3EA - Each60505-46545005251c-a161-4737-91c2-ce45d18e377012018-08-13
60505-4654-9EA - Each60505-4654f54b2c3a-4a8a-489a-956f-c6550668dc9512018-08-13

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4654-36050546540330 TABLET, FILM COATED in 1 BOTTLE (60505-4654-3) 2018-08-230000-00-00NoNoCurrent
60505-4654-96050546540990 TABLET, FILM COATED in 1 BOTTLE (60505-4654-9) 2018-08-230000-00-00NoNoCurrent