Etodolac

Product NDC: 68788-7315
Requested package NDC: 68788-7315-3
11-digit product format: 687887315
Labeler code: 68788
Product ID: 68788-7315_dc20bec2-e885-442a-93bb-2de09faa44c9
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: 2019-01-02
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: 2027-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2021-12-28 21:50 UTC	2021-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`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	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…`
2021-12-28 21:50 UTC	2021-12	A208834-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208834-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 68788-7315-3 ndc (product): 68788-7315 ndc11 (package): 68788731503
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

Additional Listing Data#

Finished product: Yes
Brand name base: Etodolac
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETODOLAC	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2M36281008	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197686	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55ae2e78-d803-496b-b66d-af1140312785	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7	Product name	1	20250311
0c3d95a8-02c3-425e-810b-2a14408d9a06	Product name	4	20250218
24aa5265-325f-0e21-8836-2c9a907c0454	Product name	2	20210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7315-1	Etodolac	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
68788-7315-2	Etodolac	20 in 1 BOTTLE	TABLET, FILM COATED	20	7
68788-7315-3	Etodolac	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
68788-7315-6	Etodolac	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
68788-7315-9	Etodolac	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7315	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 5 package rows	20250504_55ae2e78-d803-496b-b66d-af1140312785.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197686	etodolac 400 MG Oral Tablet	PSN	55ae2e78-d803-496b-b66d-af1140312785	7
197686	etodolac 400 MG Oral Tablet	SCD	55ae2e78-d803-496b-b66d-af1140312785	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7315-3	68788731503	30 TABLET, FILM COATED in 1 BOTTLE (68788-7315-3)	2019-01-02	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.	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	7