Etodolac

Product NDC
71335-0640
11-digit product format
713350640
Labeler code
71335
Product ID
71335-0640_83318a31-9968-4f58-915d-de889f193693
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074903
Marketing category
ANDA
Marketing start
2015-04-20
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
2021-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0640DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-064071335-0640-7DDiscontinued by firm2026-08-17

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 · 96 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 packagepackage71335-0640-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0640-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0640-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0640-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0640-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0640-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0640-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0640-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0640-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0640-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0640-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0640-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0640-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0640-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0640-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0640-1ed331223b511…672a5bd82f5f…

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
A074903-001ETODOLACETODOLAC400MGTABLET / ORALAB1997-04-11
A074903-002ETODOLACETODOLAC500MGTABLET / ORALAB1999-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074903-001AB
A074903-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074903-001ETODOLAC400MGTABLET / ORALAB1997-04-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074903-002ETODOLAC500MGTABLET / ORALAB1999-04-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074903-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074903-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074903-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074903-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074903-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074903-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074903-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074903-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074903-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074903-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074903-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074903-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074903-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074903-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074903-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074903-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074903-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074903-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074903-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074903-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074903-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074903-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074903-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074903-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074903-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074903-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074903-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074903-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074903-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074903-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074903-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074903-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074903-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074903-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074903-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074903-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074903-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074903-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074903-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074903-002AB1bb7c543d1eb4…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0640-17133506400160 TABLET, COATED in 1 BOTTLE (71335-0640-1) 2018-01-150000-00-00NoNoCurrent
71335-0640-27133506400290 TABLET, COATED in 1 BOTTLE (71335-0640-2) 2018-01-150000-00-00NoNoCurrent
71335-0640-37133506400330 TABLET, COATED in 1 BOTTLE (71335-0640-3) 2018-01-150000-00-00NoNoCurrent
71335-0640-471335064004100 TABLET, COATED in 1 BOTTLE (71335-0640-4) 2018-01-150000-00-00NoNoCurrent
71335-0640-5713350640056 TABLET, COATED in 1 BOTTLE (71335-0640-5) 2018-01-150000-00-00NoNoCurrent
71335-0640-67133506400620 TABLET, COATED in 1 BOTTLE (71335-0640-6) 2018-01-150000-00-00NoNoCurrent
71335-0640-77133506400714 TABLET, COATED in 1 BOTTLE (71335-0640-7) 2018-01-150000-00-00NoNoCurrent