Etodolac

Product NDC: 71335-1958
11-digit product format: 713351958
Labeler code: 71335
Product ID: 71335-1958_45dc5310-0271-4d79-bfe3-5a4dcf71c6ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075074
Marketing category: ANDA
Marketing start: 1998-03-11
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 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: 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
03458123-e27c-4447-9ef3-3bd32481cb97	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
71335-1958-1	Etodolac	20 in 1 BOTTLE	TABLET, FILM COATED	20	102
71335-1958-2	Etodolac	14 in 1 BOTTLE	TABLET, FILM COATED	14	102
71335-1958-3	Etodolac	30 in 1 BOTTLE	TABLET, FILM COATED	30	102
71335-1958-4	Etodolac	100 in 1 BOTTLE	TABLET, FILM COATED	100	102
71335-1958-5	Etodolac	60 in 1 BOTTLE	TABLET, FILM COATED	60	102
71335-1958-6	Etodolac	90 in 1 BOTTLE	TABLET, FILM COATED	90	102
71335-1958-7	Etodolac	56 in 1 BOTTLE	TABLET, FILM COATED	56	102
71335-1958-8	Etodolac	120 in 1 BOTTLE	TABLET, FILM COATED	120	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1958-1	EA - Each	71335-1958	cfe6796e-6bc0-4b91-9d4f-5379a2e19f8b	1	2026-04-20
71335-1958-2	EA - Each	71335-1958	f59b487a-e83d-4fce-922b-58072c6255ab	1	2026-04-20
71335-1958-3	EA - Each	71335-1958	061db1d0-de90-4d4d-9829-40f44be311e4	1	2026-04-20
71335-1958-4	EA - Each	71335-1958	e3bc1e35-4152-4fde-88c5-fc419adde2c5	1	2026-04-20
71335-1958-5	EA - Each	71335-1958	53c0b0c9-c9dc-40a5-8bcd-0fd04d768243	1	2026-04-20
71335-1958-6	EA - Each	71335-1958	529df53c-dcb3-4a6e-bb6e-45bd7b39babb	1	2026-04-20
71335-1958-7	EA - Each	71335-1958	474c5157-b6e4-4fd9-9bfb-c55336b5fb62	1	2026-04-20
71335-1958-8	EA - Each	71335-1958	1bdfd101-d644-4c9a-9c08-9b4c3a8810a6	1	2026-04-20

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Bryant Ranch Prepack	03458123-e27c-4447-9ef3-3bd32481cb97	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074 ndc (product): 71335-1958
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
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	Golden State Medical Supply, Inc.	cf17926c-ed90-4fd0-80af-ccee084075e8	2024-11-25	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
197686	etodolac 400 MG Oral Tablet	PSN	03458123-e27c-4447-9ef3-3bd32481cb97	102
197686	etodolac 400 MG Oral Tablet	SCD	03458123-e27c-4447-9ef3-3bd32481cb97	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1958-1	71335195801	20 TABLET, FILM COATED in 1 BOTTLE (71335-1958-1)	2021-10-06	0000-00-00	No	No	Current
71335-1958-2	71335195802	14 TABLET, FILM COATED in 1 BOTTLE (71335-1958-2)	2021-10-06	0000-00-00	No	No	Current
71335-1958-3	71335195803	30 TABLET, FILM COATED in 1 BOTTLE (71335-1958-3)	2021-10-06	0000-00-00	No	No	Current
71335-1958-4	71335195804	100 TABLET, FILM COATED in 1 BOTTLE (71335-1958-4)	2021-10-06	0000-00-00	No	No	Current
71335-1958-5	71335195805	60 TABLET, FILM COATED in 1 BOTTLE (71335-1958-5)	2021-10-06	0000-00-00	No	No	Current
71335-1958-6	71335195806	90 TABLET, FILM COATED in 1 BOTTLE (71335-1958-6)	2021-10-06	0000-00-00	No	No	Current
71335-1958-7	71335195807	56 TABLET, FILM COATED in 1 BOTTLE (71335-1958-7)	2021-10-06	0000-00-00	No	No	Current
71335-1958-8	71335195808	120 TABLET, FILM COATED in 1 BOTTLE (71335-1958-8)	2021-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules and Tablets, USP	Bryant Ranch Prepack	2026-08-20	HUMAN PRESCRIPTION DRUG LABEL	103