Etodolac

Product NDC: 60760-281
Requested package NDC: 60760-281-15
11-digit product format: 607600281
Labeler code: 60760
Product ID: 60760-281_7a8e2c72-4d45-2680-e053-2991aa0a73d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA091134
Marketing category: ANDA
Marketing start: 2018-02-14
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 600 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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60760-281	60760-281-15	D	Discontinued by firm		2026-08-17

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091134-001	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23
A091134-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23
A091134-003	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091134-001	AB
A091134-002	AB
A091134-003	AB

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091134-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091134-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-281-15	EA - Each	60760-281	f77607e9-8279-4ac2-82f9-bf980f0fa762	1	2018-03-08
60760-281-30	EA - Each	60760-281	d4b9a32b-cc4c-455b-bd66-b9aba134e059	1	2018-03-08

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	St. Mary's Medical Park Pharmacy	6761e6b1-2399-4643-e053-2991aa0a6f17	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	NuCare Pharmaceuticals, Inc.	27e98e6d-9fad-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Zydus Lifesciences Limited	0c5f8631-f013-4bbb-b610-0a8a1311844e	2024-11-28		Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Bryant Ranch Prepack	1e4824cc-4d52-4f20-9674-cfcb9ee66574	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Zydus Pharmaceuticals USA Inc.	7ef79e43-0628-4795-937e-ebb752d79133	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	15d6bc8e-1e25-6676-e063-6294a90a0035	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Proficient Rx LP	4712e069-83b6-4052-8d95-f59ab1dba744	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2M36281008	ETODOLAC	41340-25-4	ETODOLAC

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-281-15	60760028115	15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-281-15)	2018-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Extended-release Tablets, USP	St. Mary's Medical Park Pharmacy \| Cadila Healthcare Limited	2018-11-13	HUMAN PRESCRIPTION DRUG LABEL	3