Etodolac

Product NDC: 71205-140
11-digit product format: 712050140
Labeler code: 71205
Product ID: 71205-140_524617eb-4404-4d2e-8d0c-478294af8a27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA075665
Marketing category: ANDA
Marketing start: 2001-02-09
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075665-001	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31
A075665-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31
A075665-003	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075665-001	AB
A075665-002	AB
A075665-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A075665-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075665-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075665-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075665-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075665-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Etodolac
Listing expiration: 2026-12-31

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
310245	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
5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	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
71205-140-30	Etodolac	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	3
71205-140-60	Etodolac	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	3
71205-140-90	Etodolac	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-140	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20241024_5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Proficient Rx LP	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075665 application number: ANDA075665 ndc (product): 71205-140
Etodolac	ETODOLAC	Teva Pharmaceuticals USA, Inc.	f3bf1675-8fda-40d3-8427-0a6a6133a3d3	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075665 application number: ANDA075665

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
310245	etodolac 400 MG 24HR Extended Release Oral Tablet	PSN	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	3
310245	24 HR etodolac 400 MG Extended Release Oral Tablet	SCD	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	3
310245	etodolac 400 MG 24 HR Extended Release Oral Tablet	SY	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-140-30	71205014030	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-30)	2018-10-31	0000-00-00	No	No	Current
71205-140-60	71205014060	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-60)	2018-10-31	0000-00-00	No	No	Current
71205-140-90	71205014090	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-90)	2018-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETODOLAC EXTENDED-RELEASE TABLETS Rx only	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	3