Etodolac

Product NDC: 80425-0381
11-digit product format: 804250381
Labeler code: 80425
Product ID: 80425-0381_15d6ab3c-a8ab-953b-e063-6394a90a9849
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA091134
Marketing category: ANDA
Marketing start: 2024-04-10
Substance: ETODOLAC
Active strength: 600 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 43.

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	Approval date
A091134-001	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23
A091134-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23
A091134-003	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091134-001	AB
A091134-002	AB
A091134-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091134-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091134-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091134-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091134-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETODOLAC	600 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
310247	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
15d6bc8e-1e25-6676-e063-6294a90a0035	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
0c3d95a8-02c3-425e-810b-2a14408d9a06	Product name	4	20250218
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
24aa5265-325f-0e21-8836-2c9a907c0454	Product name	2	20210601
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0381-1	Etodolac	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0381-1	EA - Each	80425-0381	c8bacf3d-9084-421b-8973-912b0027efc0	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0381	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	1	Current NDC, 1 package rows	20240413_15d6bc8e-1e25-6676-e063-6294a90a0035.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	St. Mary's Medical Park Pharmacy	6761e6b1-2399-4643-e053-2991aa0a6f17	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	NuCare Pharmaceuticals, Inc.	27e98e6d-9fad-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Zydus Lifesciences Limited	0c5f8631-f013-4bbb-b610-0a8a1311844e	2024-11-28		Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Bryant Ranch Prepack	1e4824cc-4d52-4f20-9674-cfcb9ee66574	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Zydus Pharmaceuticals USA Inc.	7ef79e43-0628-4795-937e-ebb752d79133	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	15d6bc8e-1e25-6676-e063-6294a90a0035	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134 ndc (product): 80425-0381
Etodolac	ETODOLAC	Proficient Rx LP	4712e069-83b6-4052-8d95-f59ab1dba744	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134

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
310247	etodolac 600 MG 24HR Extended Release Oral Tablet	PSN	15d6bc8e-1e25-6676-e063-6294a90a0035	1
310247	24 HR etodolac 600 MG Extended Release Oral Tablet	SCD	15d6bc8e-1e25-6676-e063-6294a90a0035	1
310247	etodolac 600 MG 24 HR Extended Release Oral Tablet	SY	15d6bc8e-1e25-6676-e063-6294a90a0035	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0381-1	80425038101	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0381-1)	2024-04-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Extended-Release Tablets, USP	Advanced Rx Pharmacy of Tennessee, LLC	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	1