Etodolac

Product NDC
33261-044
11-digit product format
332610044
Labeler code
33261
Product ID
33261-044_f67ac41b-c0aa-4443-8468-fc7e2f975da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075009
Marketing category
ANDA
Marketing start
2009-09-09
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct33261-044IInactivated by FDA2026-08-17
excluded packagepackage33261-04433261-044-30IInactivated by FDA2026-08-17
excluded packagepackage33261-04433261-044-60IInactivated by FDA2026-08-17

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 2 · 63 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 packagepackage33261-044-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-044-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-044-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-044-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-044-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-044-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-044-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-044-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-044-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-044-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-044-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-044-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-044-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-044-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-044-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-044-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-044-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-044-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-044-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-044-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-044-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-044-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-044-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-044-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-044-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-044-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-044-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-044-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-044-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-044-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-044-60fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-044-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-044-6086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-044-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-044-60bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-044-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-044-608dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-044-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-044-60e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-044-30e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075009-001ETODOLACETODOLAC400MGTABLET / ORAL1997-11-26
A075009-002ETODOLACETODOLAC500MGTABLET / ORAL1999-12-28

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075009-001ETODOLAC400MGTABLET / ORAL1997-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075009-002ETODOLAC500MGTABLET / ORAL1999-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075009-001ETODOLAC400MGTABLET / ORAL1997-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075009-002ETODOLAC500MGTABLET / ORAL1999-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075009-001ETODOLAC400MGTABLET / ORAL1997-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075009-002ETODOLAC500MGTABLET / ORAL1999-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075009-001ETODOLAC400MGTABLET / ORAL1997-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075009-002ETODOLAC500MGTABLET / ORAL1999-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075009-001ETODOLAC400MGTABLET / ORAL1997-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075009-002ETODOLAC500MGTABLET / ORAL1999-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075009-001ETODOLAC400MGTABLET / ORAL1997-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075009-002ETODOLAC500MGTABLET / ORAL1999-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075009-001ETODOLAC400MGTABLET / ORAL1997-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075009-002ETODOLAC500MGTABLET / ORAL1999-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075009-001ETODOLAC400MGTABLET / ORAL1997-11-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075009-002ETODOLAC500MGTABLET / ORAL1999-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075009-001ETODOLAC400MGTABLET / ORAL1997-11-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075009-002ETODOLAC500MGTABLET / ORAL1999-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075009-001ETODOLAC400MGTABLET / ORAL1997-11-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075009-002ETODOLAC500MGTABLET / ORAL1999-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075009-001ETODOLAC400MGTABLET / ORAL1997-11-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075009-002ETODOLAC500MGTABLET / ORAL1999-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075009-001ETODOLAC400MGTABLET / ORALAB1997-11-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075009-002ETODOLAC500MGTABLET / ORALAB1999-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075009-001ETODOLAC400MGTABLET / ORAL1997-11-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075009-002ETODOLAC500MGTABLET / ORAL1999-12-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075009-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075009-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075009-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075009-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075009-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075009-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075009-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075009-002AB1ea99ee380514…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-044-302020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only
33261-044-602020-01-31C16284748780-19d75b9d0-a2a6-f424-e053-dadaa90a57ceETODOLAC TABLETS USP 0892 1893 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-044-30Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
33261-044-60Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-044-30EA - Each33261-044751add7b-b1b2-4863-917f-191c7e5eb2f412015-10-02
33261-044-60EA - Each33261-044fe5291c3-0a96-4de4-bb78-20dea2395bbc12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-044ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20140107_dc441b8f-1012-4d07-bdb7-ce0c85480533.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSNdc441b8f-1012-4d07-bdb7-ce0c854805332
199390etodolac 500 MG Oral TabletPSNdc441b8f-1012-4d07-bdb7-ce0c854805332
197686etodolac 400 MG Oral TabletSCDdc441b8f-1012-4d07-bdb7-ce0c854805332
199390etodolac 500 MG Oral TabletSCDdc441b8f-1012-4d07-bdb7-ce0c854805332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-044-303326100443030 in 1 BOTTLE, PLASTICHistorical
33261-044-603326100446060 in 1 BOTTLE, PLASTICHistorical