Etodolac

Product NDC: 50090-1789
Requested package NDC: 50090-1789-5
11-digit product format: 500901789
Labeler code: 50090
Product ID: 50090-1789_ec4e69ab-aa22-47ea-989f-f5d546dd113f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA076004
Marketing category: ANDA
Marketing start: 2003-05-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-1789	50090-1789-5	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1789	50090-1789-5	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1789	50090-1789-5	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A076004-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2002-12-03
A076004-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2002-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076004-001	AB
A076004-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`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	A076004-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076004-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076004-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076004-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076004-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076004-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076004-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076004-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076004-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076004-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076004-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076004-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076004-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076004-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076004-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076004-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076004-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076004-002	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
50090-1789-1	EA - Each	50090-1789	c2b05c33-6f7b-479b-a2e4-5d256de50153	1	2018-10-11
50090-1789-2	EA - Each	50090-1789	660507f8-fe99-4167-ba50-1dfb7ea6fd4e	1	2018-10-11
50090-1789-5	EA - Each	50090-1789	f12cd19b-6d92-491c-89bd-079fc4c9a5fe	1	2018-09-05

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	St. Marys Medical Park Pharmacy	60cb4de0-ed88-a46b-e053-2a91aa0a8b6d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	REMEDYREPACK INC.	cad9b5ca-a9d4-41d4-aff2-67d0c458aad6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	007c55fa-ef8b-4a8e-bfe5-e47c6e5da727	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	41bd86b9-2ef3-49a4-874e-fe8ac6891080	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	556eaa67-d30d-4095-a981-c65f98d3acdd	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	REMEDYREPACK INC.	1a38815e-1903-4f03-b83e-9780c71d4971	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	80e9d756-9278-48bb-bfdd-7d070ae0f341	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Bryant Ranch Prepack	479bce92-2066-46ed-b4bb-8c7a59edfffd	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Apotex Corp.	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	556a7d5f-2c3c-4efb-ac0c-fca140791602	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	d83d9f30-c367-f8b3-e053-2a95a90a1f40	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Bryant Ranch Prepack	be53bc5c-4294-44a7-b28c-7db3f925396d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	141be3f6-198d-ce46-e063-6294a90a7993	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Medsource Pharmaceuticals	12f0685b-2127-d0d6-e063-6394a90a62d1	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Proficient Rx LP	e2fef939-2f4a-46ae-8177-073f5e8f57f5	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	A-S Medication Solutions	74baa6ad-b517-48e2-8cef-d77f5755b279	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Proficient Rx LP	0c783997-6f2a-45ae-b899-c060c8be468a	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004

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
50090-1789-5	50090178905	60 TABLET, FILM COATED in 1 BOTTLE (50090-1789-5)	2015-04-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	A-S Medication Solutions	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL	27