Etodolac

Product NDC
50090-0592
11-digit product format
500900592
Labeler code
50090
Product ID
50090-0592_d7170ea0-220d-42d6-830c-634afcb1bf3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075074
Marketing category
ANDA
Marketing start
1998-03-11
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct50090-0592DDiscontinued by firm2026-08-03
excluded packagepackage50090-059250090-0592-0DDiscontinued 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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0592-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0592-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0592-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0592-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0592-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0592-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0592-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0592-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0592-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0592-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0592-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0592-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50090-0592-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075074-001ETODOLACETODOLAC400MGTABLET / ORALAB1998-03-11
A075074-002ETODOLACETODOLAC500MGTABLET / ORALABRS2000-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075074-001AB
A075074-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075074-001ETODOLAC400MGTABLET / ORALAB1998-03-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A075074-002ETODOLAC500MGTABLET / ORALABRS2000-04-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075074-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075074-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075074-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075074-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075074-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075074-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075074-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075074-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075074-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075074-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075074-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075074-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075074-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075074-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075074-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075074-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075074-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075074-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075074-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075074-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075074-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075074-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075074-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075074-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075074-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075074-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075074-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075074-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075074-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0592-0Etodolac20 in 1 BOTTLETABLET, FILM COATED2013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0592ETODOLAC TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Legacy NDC, 1 package rows20250207_a7d91fcf-7928-4c9e-862b-6922d6e47c9d.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACSun Pharmaceutical Industries, Inc.ec82b108-6a6f-4d1b-82cb-831d4ed36c802026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACPreferred Pharmaceuticals Inc.117b3005-a8ec-4f76-824c-95ec42dc87a12026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACBryant Ranch Prepack03458123-e27c-4447-9ef3-3bd32481cb972026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACREMEDYREPACK INC.188cdd2e-4196-458c-9631-4fa9a0d309b82025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAdvanced Rx of Tennessee, LLC3d865ff0-fc45-1e95-e063-6294a90a8e182025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACA-S Medication Solutionsa7d91fcf-7928-4c9e-862b-6922d6e47c9d2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
ndc (product): 50090-0592
EtodolacETODOLACGolden State Medical Supply, Inc.cf17926c-ed90-4fd0-80af-ccee084075e82024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC2425aef0-57eb-d1a5-e063-6294a90a0bf22024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC1547f132-0d35-45cb-e063-6294a90a2efe2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC1149072a-280a-2b11-e063-6394a90ac1072024-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074
EtodolacETODOLACAphena Pharma Solutions - Tennessee, LLC420b1ed5-e9f2-43dd-8d3c-ca9896221aca2024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075074
application number: ANDA075074

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
199390etodolac 500 MG Oral TabletPSNa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
197686etodolac 400 MG Oral TabletSCDa7d91fcf-7928-4c9e-862b-6922d6e47c9d13
199390etodolac 500 MG Oral TabletSCDa7d91fcf-7928-4c9e-862b-6922d6e47c9d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0592-05009005920020 in 1 BOTTLEHistorical