Etodolac

Product NDC: 0185-0675
11-digit product format: 001850675
Labeler code: 0185
Product ID: 0185-0675_1ad440d5-7e56-4d98-ba75-56eac1fafb01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Eon Labs, Inc.
Application: ANDA074903
Marketing category: ANDA
Marketing start: 2015-04-20
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 400 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: 2023-12-31
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	0185-0675		D	Discontinued by firm	2026-08-17
excluded package	package	0185-0675	0185-0675-01	D	Discontinued by firm	2026-08-17
excluded package	package	0185-0675	0185-0675-05	D	Discontinued by firm	2026-08-17
excluded package	package	0185-0675	0185-0675-10	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 · 28 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	0185-0675-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0675-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0675-10	`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	0185-0675-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0675-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0675-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0675-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0675-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0675-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0675-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0675-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0675-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0675-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0675-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0675-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0675-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0675-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0675-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0675-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0675-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0675-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0675-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0675-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0675-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0675-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0675-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074903-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		1997-04-11
A074903-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		1999-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074903-001	AB
A074903-002	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 · 84 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	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A074903-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074903-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074903-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074903-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074903-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074903-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074903-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0675-01	EA - Each	0185-0675	eb33100c-b072-4b81-a041-29a73674ca3d	1	2015-07-20
0185-0675-10	EA - Each	0185-0675	9a555273-9e64-47b4-b6dd-3f55d5fe0fc4	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ETODOLAC TABLET, COATED [EON LABS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, COATED [EON LABS, INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-0675	ETODOLAC TABLET, COATED [EON LABS, INC.]	20	Legacy NDC	20231102_ba37476d-05a4-48cb-9cee-6b10e0dd5bf4.zip

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
0185-0675-01	00185067501	100 TABLET, COATED in 1 BOTTLE (0185-0675-01)	2015-04-20	0000-00-00	No	No	Current
0185-0675-05	00185067505	500 TABLET, COATED in 1 BOTTLE (0185-0675-05)	2015-04-20	0000-00-00	No	No	Current
0185-0675-10	00185067510	1000 TABLET, COATED in 1 BOTTLE (0185-0675-10)	2015-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	19
Etodolac Tablets, USP	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	5
Etodolac Tablets, USP	Eon Labs, Inc.	2021-03-12	HUMAN PRESCRIPTION DRUG LABEL	20
ETODOLAC TABLETS USP	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
Etodolac Tablets, USP	Preferred Pharmaceuticals Inc.	2020-05-18	HUMAN PRESCRIPTION DRUG LABEL	3