Etodolac

Product NDC: 68788-7300
11-digit product format: 687887300
Labeler code: 68788
Product ID: 68788-7300_e524f1e9-d4d7-45fc-a011-4466bfbc7109
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA208834
Marketing category: ANDA
Marketing start: 2019-01-07
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 500 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7300		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7300	68788-7300-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7300	68788-7300-2	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7300	68788-7300-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7300	68788-7300-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7300	68788-7300-8	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7300	68788-7300-9	D	Discontinued by firm	2026-08-17

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
A208834-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2018-06-07
A208834-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2018-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208834-001	AB
A208834-002	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	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`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	A208834-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208834-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208834-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208834-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208834-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208834-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208834-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208834-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208834-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208834-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208834-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208834-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208834-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208834-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208834-002	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
68788-7300-1	EA - Each	68788-7300	670a006a-e876-495b-979d-98b2d4fb7277	1	2019-04-11
68788-7300-2	EA - Each	68788-7300	91f5d414-f2a1-4626-ba48-1377f07a5c99	1	2019-04-11
68788-7300-3	EA - Each	68788-7300	6d0a42b9-c7f3-4fa5-a004-c83595fa3947	1	2019-04-11
68788-7300-6	EA - Each	68788-7300	73e0faa3-fca2-460f-a083-46dfe8b82c4b	1	2019-04-11
68788-7300-8	EA - Each	68788-7300	ee3f5883-cc94-42e0-bd80-0c365953b394	1	2019-04-11
68788-7300-9	EA - Each	68788-7300	db871587-3dc0-4c6b-b897-c33f9351fc03	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7300	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	9	Legacy NDC	20250507_2ade1463-452e-4a62-a632-5f8629176535.zip

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	55ae2e78-d803-496b-b66d-af1140312785	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	336d5331-4d60-42e2-8cfc-aad57c01eda0	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	00125d63-d8d0-46c5-bdf1-80d2c85eda5a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Northwind Health Company, LLC	b0880f39-a6fa-23ab-e053-2995a90a7eb2	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Northwind Health Company, LLC	da34581d-3066-711c-e053-2995a90a8e84	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	c18497e2-9fca-4500-e053-2a95a90a1bcc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Amneal Pharmaceuticals NY LLC	2f306e69-c109-4e60-aaf3-9016a4e2cc33	2024-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Bryant Ranch Prepack	4b0d1245-8d01-4fff-9783-cb30c17d9246	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Bryant Ranch Prepack	53160db5-ba48-4cac-afbe-acd608daa0dc	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	113558e6-8b45-cdbd-e063-6394a90ac036	2024-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	31a55fb1-9721-4202-af7d-f06074b03102	2023-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Doc Rx	cdde46e5-1123-410f-aafc-0c6e904a5d5b	2021-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834

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
68788-7300-1	68788730001	100 TABLET, FILM COATED in 1 BOTTLE (68788-7300-1)	2019-01-07	0000-00-00	No	No	Current
68788-7300-2	68788730002	20 TABLET, FILM COATED in 1 BOTTLE (68788-7300-2)	2019-01-07	0000-00-00	No	No	Current
68788-7300-3	68788730003	30 TABLET, FILM COATED in 1 BOTTLE (68788-7300-3)	2019-01-07	0000-00-00	No	No	Current
68788-7300-6	68788730006	60 TABLET, FILM COATED in 1 BOTTLE (68788-7300-6)	2019-01-07	0000-00-00	No	No	Current
68788-7300-8	68788730008	120 TABLET, FILM COATED in 1 BOTTLE (68788-7300-8)	2019-01-07	0000-00-00	No	No	Current
68788-7300-9	68788730009	90 TABLET, FILM COATED in 1 BOTTLE (68788-7300-9)	2019-01-07	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	Preferred Pharmaceuticals Inc.	2025-05-02	HUMAN PRESCRIPTION DRUG LABEL	9