Etodolac

Product NDC
60429-315
Requested package NDC
60429-315-01
11-digit product format
604290315
Labeler code
60429
Product ID
60429-315_e6d9606c-ac46-b89c-e053-2995a90ac780
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA076174
Marketing category
ANDA
Marketing start
2003-03-13
Marketing end
2024-01-31
Substance
ETODOLAC
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage60429-31560429-315-01DDiscontinued by firm2026-08-03
excluded packagepackage60429-31560429-315-01DDiscontinued 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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
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
A076174-001ETODOLACETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13
A076174-002ETODOLACETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13
A076174-003ETODOLACETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076174-001AB
A076174-002AB
A076174-003AB

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 UTC2026-02A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076174-002ETODOLAC500MGTABLET, EXTENDED RELEASE / ORALAB2003-03-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076174-003ETODOLAC600MGTABLET, EXTENDED RELEASE / ORALAB2003-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076174-001ETODOLAC400MGTABLET, EXTENDED RELEASE / ORALAB2003-03-138072bd15b7f6…

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 UTC2026-02A076174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076174-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076174-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076174-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076174-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076174-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076174-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076174-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076174-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076174-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076174-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076174-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076174-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076174-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076174-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076174-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076174-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076174-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076174-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076174-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076174-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076174-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076174-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076174-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076174-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076174-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-315-01Etodolac100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-315-01EA - Each60429-315dcf7ec80-4f07-48c3-94fb-ce8aba4e13f512012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-315ETODOLAC TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]4Legacy NDC, 1 package rows20250101_c59c5108-a09b-2a03-e053-2995a90abba1.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACTaSun Pharmaceutical Industries, Inc.2c5b44b4-78d5-43b2-827d-d2763b6672b32026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076174
application number: ANDA076174
EtodolacETODOLACNORTHSTAR RX LLC107ea9d7-80a9-41a4-b61e-1683701273192025-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076174
application number: ANDA076174
Etodolac ERETODOLACAdvanced Rx Pharmacy of Tennessee, LLCd294d541-3049-6bfe-e053-2995a90a23ea2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076174
application number: ANDA076174
Etodolac ERETODOLACAdvanced Rx Pharmacy of Tennessee, LLCbaebdfb2-17f6-9081-e053-2a95a90ab3312024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076174
application number: ANDA076174
EtodolacETODOLACGolden State Medical Supply, Inc.c59c5108-a09b-2a03-e053-2995a90abba12024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076174
application number: ANDA076174
ndc (package): 60429-315-01
ndc (product): 60429-315
ndc11 (package): 60429031501
EtodolacETODOLACProficient Rx LP449b273a-936a-4c49-b0c8-d0daa47733ae2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076174
application number: ANDA076174

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310245etodolac 400 MG 24HR Extended Release Oral TabletPSNc59c5108-a09b-2a03-e053-2995a90abba14
359500etodolac 500 MG 24HR Extended Release Oral TabletPSNc59c5108-a09b-2a03-e053-2995a90abba14
310247etodolac 600 MG 24HR Extended Release Oral TabletPSNc59c5108-a09b-2a03-e053-2995a90abba14
31024524 HR etodolac 400 MG Extended Release Oral TabletSCDc59c5108-a09b-2a03-e053-2995a90abba14
35950024 HR etodolac 500 MG Extended Release Oral TabletSCDc59c5108-a09b-2a03-e053-2995a90abba14
31024724 HR etodolac 600 MG Extended Release Oral TabletSCDc59c5108-a09b-2a03-e053-2995a90abba14
310245etodolac 400 MG 24 HR Extended Release Oral TabletSYc59c5108-a09b-2a03-e053-2995a90abba14
359500etodolac 500 MG 24 HR Extended Release Oral TabletSYc59c5108-a09b-2a03-e053-2995a90abba14
310247etodolac 600 MG 24 HR Extended Release Oral TabletSYc59c5108-a09b-2a03-e053-2995a90abba14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-315-0160429031501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-315-01) 2011-07-182024-01-31NoNoCurrent