Etodolac

Product NDC
16714-498
11-digit product format
167140498
Labeler code
16714
Product ID
16714-498_38568f45-b334-0e6f-e063-6294a90a178a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA076174
Marketing category
ANDA
Marketing start
2003-03-13
Substance
ETODOLAC
Active strength
500 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
2026-12-31
Current FDA listing
Yes

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 packagepackage16714-49816714-498-01DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-49816714-498-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-49816714-498-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2M36281008Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310245Internal RxNorm lookup
310247Internal RxNorm lookup
359500Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
107ea9d7-80a9-41a4-b61e-168370127319Available on FDA.report

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
16714-498-01Etodolac60 in 1 BOTTLETABLET, EXTENDED RELEASE605
16714-498-02Etodolac100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-498-01EA - Each16714-498c3a58eb1-7046-469f-a262-da090171563912016-12-07
16714-498-02EA - Each16714-498a2bf2efe-5835-4a59-b687-5690fd78f7d212016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-498ETODOLAC TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 2 package rows20241019_107ea9d7-80a9-41a4-b61e-168370127319.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
ndc (product): 16714-498
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
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 TabletPSN107ea9d7-80a9-41a4-b61e-1683701273195
359500etodolac 500 MG 24HR Extended Release Oral TabletPSN107ea9d7-80a9-41a4-b61e-1683701273195
310247etodolac 600 MG 24HR Extended Release Oral TabletPSN107ea9d7-80a9-41a4-b61e-1683701273195
31024524 HR etodolac 400 MG Extended Release Oral TabletSCD107ea9d7-80a9-41a4-b61e-1683701273195
35950024 HR etodolac 500 MG Extended Release Oral TabletSCD107ea9d7-80a9-41a4-b61e-1683701273195
31024724 HR etodolac 600 MG Extended Release Oral TabletSCD107ea9d7-80a9-41a4-b61e-1683701273195
310245etodolac 400 MG 24 HR Extended Release Oral TabletSY107ea9d7-80a9-41a4-b61e-1683701273195
359500etodolac 500 MG 24 HR Extended Release Oral TabletSY107ea9d7-80a9-41a4-b61e-1683701273195
310247etodolac 600 MG 24 HR Extended Release Oral TabletSY107ea9d7-80a9-41a4-b61e-1683701273195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-498-011671404980160 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-498-01) 2016-08-150000-00-00NoNoCurrent
16714-498-0216714049802100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-498-02) 2016-08-150000-00-00NoNoCurrent