Etodolac

Product NDC: 42799-111
11-digit product format: 427990111
Labeler code: 42799
Product ID: 42799-111_462de1d4-dc95-527d-e063-6394a90ad55a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Edenbridge Pharmaceuticals LLC.
Application: ANDA209888
Marketing category: ANDA
Marketing start: 2018-12-07
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42799-111	42799-111-02	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209888-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2018-11-30
A209888-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2018-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209888-001	AB
A209888-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209888-001	ETODOLAC	400MG	TABLET / ORAL		2018-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209888-002	ETODOLAC	500MG	TABLET / ORAL		2018-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209888-001	ETODOLAC	400MG	TABLET / ORAL		2018-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209888-002	ETODOLAC	500MG	TABLET / ORAL		2018-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209888-001	ETODOLAC	400MG	TABLET / ORAL		2018-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209888-002	ETODOLAC	500MG	TABLET / ORAL		2018-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209888-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209888-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-11-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A209888-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209888-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209888-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209888-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209888-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209888-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209888-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209888-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209888-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209888-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209888-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209888-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209888-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209888-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209888-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209888-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209888-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209888-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209888-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209888-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209888-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209888-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209888-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209888-002	AB	1	`79d66fd596c7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209888-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209888-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209888-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209888-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209888-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209888-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209888-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209888-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209888-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209888-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209888-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209888-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209888-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209888-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209888-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209888-002	AB	1	`5aa47cf7b7d7…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197686	Internal RxNorm lookup
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
bf1afcd5-e1da-4874-981f-f252cb0b32c2	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
42799-111-01	Etodolac	100 in 1 BOTTLE	TABLET, FILM COATED	100		11
42799-111-02	Etodolac	500 in 1 BOTTLE	TABLET, FILM COATED	500		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42799-111-01	EA - Each	42799-111	55fb97fa-60c7-4244-a740-6fbb5f24e2a5	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42799-111	ETODOLAC TABLET, FILM COATED [EDENBRIDGE PHARMACEUTICALS LLC.]	9	Current NDC, Legacy NDC, 2 package rows	20250123_bf1afcd5-e1da-4874-981f-f252cb0b32c2.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	Edenbridge Pharmaceuticals LLC.	bf1afcd5-e1da-4874-981f-f252cb0b32c2	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209888 application number: ANDA209888 ndc (product): 42799-111
Etodolac	ETODOLAC	Chartwell RX, LLC	f86d2b22-d3f7-49cd-98f6-cdb2bd855192	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209888 application number: ANDA209888

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	bf1afcd5-e1da-4874-981f-f252cb0b32c2	11
199390	etodolac 500 MG Oral Tablet	PSN	bf1afcd5-e1da-4874-981f-f252cb0b32c2	11
197686	etodolac 400 MG Oral Tablet	SCD	bf1afcd5-e1da-4874-981f-f252cb0b32c2	11
199390	etodolac 500 MG Oral Tablet	SCD	bf1afcd5-e1da-4874-981f-f252cb0b32c2	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42799-111-01	42799011101	100 TABLET, FILM COATED in 1 BOTTLE (42799-111-01)	2018-12-07	0000-00-00	No	No	Current
42799-111-02	42799011102	500 TABLET, FILM COATED in 1 BOTTLE (42799-111-02)	2018-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac - Edenbridge Pharmaceuticals LLC. \| Adaptis Pharma Private Limited	Edenbridge Pharmaceuticals LLC. \| Adaptis Pharma Private Limited	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	11