Etodolac

Product NDC: 70518-4291
11-digit product format: 705184291
Labeler code: 70518
Product ID: 70518-4291_47178d07-88de-688e-e063-6394a90ab8a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075074
Marketing category: ANDA
Marketing start: 2025-02-25
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: 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075074-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11
A075074-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075074-001	AB
A075074-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`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	A075074-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075074-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075074-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075074-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075074-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075074-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075074-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075074-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075074-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075074-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075074-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075074-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075074-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075074-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075074-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075074-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075074-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075074-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETODOLAC	500 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
199390	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
188cdd2e-4196-458c-9631-4fa9a0d309b8	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	Strength	SPL version
70518-4291-0	Etodolac	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4291	ETODOLAC TABLET, FILM COATED [REMEDYREPACK INC.]	1	Current NDC, 1 package rows	20250227_188cdd2e-4196-458c-9631-4fa9a0d309b8.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Bryant Ranch Prepack	03458123-e27c-4447-9ef3-3bd32481cb97	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Sun Pharmaceutical Industries, Inc.	ec82b108-6a6f-4d1b-82cb-831d4ed36c80	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	117b3005-a8ec-4f76-824c-95ec42dc87a1	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	REMEDYREPACK INC.	188cdd2e-4196-458c-9631-4fa9a0d309b8	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074 ndc (product): 70518-4291
Etodolac	ETODOLAC	Advanced Rx of Tennessee, LLC	3d865ff0-fc45-1e95-e063-6294a90a8e18	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	A-S Medication Solutions	a7d91fcf-7928-4c9e-862b-6922d6e47c9d	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	2425aef0-57eb-d1a5-e063-6294a90a0bf2	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1547f132-0d35-45cb-e063-6294a90a2efe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1149072a-280a-2b11-e063-6394a90ac107	2024-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	420b1ed5-e9f2-43dd-8d3c-ca9896221aca	2024-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074

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
199390	etodolac 500 MG Oral Tablet	PSN	188cdd2e-4196-458c-9631-4fa9a0d309b8	3
199390	etodolac 500 MG Oral Tablet	SCD	188cdd2e-4196-458c-9631-4fa9a0d309b8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4291-0	70518429100	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4291-0)	2025-02-25	No	No	Current