olmesartan medoxomil

Product NDC
42291-543
11-digit product format
422910543
Labeler code
42291
Product ID
42291-543_d57d3921-085b-6640-e053-2a95a90a6116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA208130
Marketing category
ANDA
Marketing start
2018-09-17
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-543DDiscontinued by firm2026-08-03
excluded packagepackage42291-54342291-543-30DDiscontinued 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 · 24 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 packagepackage42291-543-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-543-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-543-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-543-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-543-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-543-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-543-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-543-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-543-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-543-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-543-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-543-30557ba5c1ecfa…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
A208130-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29
A208130-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29
A208130-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208130-001AB
A208130-002AB
A208130-003AB

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 UTC2026-02A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208130-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2018-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208130-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2018-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208130-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2018-06-298072bd15b7f6…

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 UTC2026-02A208130-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208130-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208130-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208130-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208130-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208130-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208130-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208130-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208130-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208130-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208130-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208130-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208130-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208130-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208130-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208130-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208130-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208130-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208130-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208130-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208130-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208130-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208130-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208130-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208130-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208130-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208130-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208130-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208130-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208130-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208130-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208130-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208130-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208130-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208130-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208130-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208130-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208130-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208130-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208130-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-543-30EA - Each42291-5434a48a7fb-4a7c-4a34-a242-f5b75686a72612018-11-06

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx4a2aad53-fcba-2a61-e063-6394a90a60162026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.fe6e39da-fb6e-46da-9c03-c765020a7c872026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILGolden State Medical Supply, Inc.865c2765-5072-d029-e053-2a91aa0a098e2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack8466711a-3a02-4675-96db-c7cffdb897782025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack640936ee-55a6-47ae-a1ad-cffae316b9252025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.1be698df-30a0-4117-8c24-7253af94c8ad2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack25431c8c-9f6e-42e7-ab84-4b062755bfe32024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepackfe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepackc35408d2-a4b5-43de-8dab-f74a60fa98532024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack409e06ad-2ea9-4b47-829e-57139e22eac92023-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130
olmesartan medoxomilOLMESARTAN MEDOXOMILScieGen Pharmaceuticals, Inc.f15664a4-6b5f-4e88-ad56-c827ed90a40c2021-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208130
application number: ANDA208130

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-543-304229105433030 TABLET, FILM COATED in 1 BOTTLE (42291-543-30) 2018-09-170000-00-00NoNoCurrent