ETODOLAC

Product NDC: 61919-092
11-digit product format: 619190092
Labeler code: 61919
Product ID: 61919-092_87bfc550-b6cb-0e26-e053-2995a90aec82
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ETODOLAC
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA075074
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 400 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-092		D	Discontinued by firm	2026-08-03
excluded package	package	61919-092	61919-092-30	D	Discontinued by firm	2026-08-03
excluded package	package	61919-092	61919-092-60	D	Discontinued by firm	2026-08-03
excluded package	package	61919-092	61919-092-90	D	Discontinued by firm	2026-08-03

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-092-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-092-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-092-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-092-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-092-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-092-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-092-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-092-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-092-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-092-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-092-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-092-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-092-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-092-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-092-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-092-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-092-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-092-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-092-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-092-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-092-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-092-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-092-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-092-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-092-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-092-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-092-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-092-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-092-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-092-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-092-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-092-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-092-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-092-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-092-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-092-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075074-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11
A075074-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075074-001	AB
A075074-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075074-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075074-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075074-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075074-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075074-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075074-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075074-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075074-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075074-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075074-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075074-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075074-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075074-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075074-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075074-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075074-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075074-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075074-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-092-30	EA - Each	61919-092	ee536487-f72a-43b2-8c19-bc67c1af165e	1	2015-10-02
61919-092-60	EA - Each	61919-092	89bd99de-393d-4454-8f57-c6a5a4aadea9	1	2015-10-02
61919-092-90	EA - Each	61919-092	44c470bb-9f7d-4b59-85b2-ce72804c4044	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Povidone	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Sun Pharmaceutical Industries, Inc.	ec82b108-6a6f-4d1b-82cb-831d4ed36c80	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	117b3005-a8ec-4f76-824c-95ec42dc87a1	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Bryant Ranch Prepack	03458123-e27c-4447-9ef3-3bd32481cb97	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	REMEDYREPACK INC.	188cdd2e-4196-458c-9631-4fa9a0d309b8	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Advanced Rx of Tennessee, LLC	3d865ff0-fc45-1e95-e063-6294a90a8e18	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	A-S Medication Solutions	a7d91fcf-7928-4c9e-862b-6922d6e47c9d	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Golden State Medical Supply, Inc.	cf17926c-ed90-4fd0-80af-ccee084075e8	2024-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	2425aef0-57eb-d1a5-e063-6294a90a0bf2	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1547f132-0d35-45cb-e063-6294a90a2efe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1149072a-280a-2b11-e063-6394a90ac107	2024-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	420b1ed5-e9f2-43dd-8d3c-ca9896221aca	2024-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074

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
61919-092-30	61919009230	30 TABLET, FILM COATED in 1 BOTTLE (61919-092-30)	2015-01-01	0000-00-00	No	No	Current
61919-092-60	61919009260	60 TABLET, FILM COATED in 1 BOTTLE (61919-092-60)	2015-01-01	0000-00-00	No	No	Current
61919-092-90	61919009290	90 TABLET, FILM COATED in 1 BOTTLE (61919-092-90)	2015-01-01	0000-00-00	No	No	Current