Etodolac

Product NDC: 68788-7315
Requested package NDC: 68788-7315-1
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…`

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

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 ndc (package): 68788-7315-1 ndc (product): 68788-7315 ndc11 (package): 68788731501
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

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
68788-7315-1	68788731501	100 TABLET, FILM COATED in 1 BOTTLE (68788-7315-1)	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