Benicar

Product NDC
50090-0877
Requested package NDC
50090-0877-0
11-digit product format
500900877
Labeler code
50090
Product ID
50090-0877_01dc0513-a4bf-420f-8908-d9a3e1bc3580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021286
Marketing category
NDA
Marketing start
2002-04-25
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-087750090-0877-0DDiscontinued 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
N021286-001BENICAROLMESARTAN MEDOXOMIL5MGTABLET / ORALABRLD2002-04-25
N021286-003BENICAROLMESARTAN MEDOXOMIL20MGTABLET / ORALABRLD2002-04-25
N021286-004BENICAROLMESARTAN MEDOXOMIL40MGTABLET / ORALABRLD, RS2002-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021286-001AB
N021286-003AB
N021286-004AB

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 UTC2026-02N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021286-003BENICAR20MGTABLET / ORALABRLD2002-04-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021286-004BENICAR40MGTABLET / ORALABRLD, RS2002-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021286-001BENICAR5MGTABLET / ORALABRLD2002-04-258072bd15b7f6…

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 UTC2026-02N021286-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021286-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021286-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021286-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021286-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021286-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021286-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021286-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021286-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021286-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021286-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021286-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021286-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021286-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021286-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021286-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021286-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021286-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021286-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021286-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021286-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021286-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021286-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021286-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021286-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021286-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021286-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021286-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021286-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021286-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021286-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021286-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021286-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021286-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021286-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021286-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021286-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021286-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021286-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021286-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0877-0EA - Each50090-08777ad80574-a6a8-49fe-a0b1-89441c1354d612018-10-11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenicarOLMESARTAN MEDOXOMILCosette Pharmaceuticals, Inc.dc3f1fd4-5578-4c5d-be7b-12e3f8f3e7df2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021286
application number: NDA021286
BenicarOLMESARTAN MEDOXOMILCosette Pharmaceuticals, Inc.5b6f8a18-8f8a-4521-81c3-3a39c73c66462023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021286
application number: NDA021286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0877-05009008770030 TABLET, FILM COATED in 1 BOTTLE (50090-0877-0) 2014-11-280000-00-00NoNoCurrent