Etodolac

Product NDC: 71335-1230
11-digit product format: 713351230
Labeler code: 71335
Product ID: 71335-1230_f91abb0f-25ae-4086-81b9-6d23820e5108
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA208834
Marketing category: ANDA
Marketing start: 2018-06-11
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

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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1230		D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-1	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-2	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-3	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-4	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-5	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-6	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1230	71335-1230-7	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 2 · 112 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1230-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1230-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1230-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1230-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1230-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1230-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1230-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-1230-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-1230-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-1230-3	`ed331223b511…`	`672a5bd82f5f…`

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
A208834-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2018-06-07
A208834-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2018-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208834-001	AB
A208834-002	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	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`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	A208834-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208834-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208834-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208834-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208834-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208834-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208834-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208834-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208834-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208834-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208834-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208834-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208834-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208834-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208834-002	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
4b0d1245-8d01-4fff-9783-cb30c17d9246	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-1230-1	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-2	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-3	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-4	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-5	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-6	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-7	2024-05-20	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-1	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-2	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-3	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-4	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-5	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-6	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only
71335-1230-7	2024-01-30	Etodolac Tablets, USP (400 mg and 500 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1230-1	Etodolac	60 in 1 BOTTLE	TABLET, FILM COATED	60	101
71335-1230-2	Etodolac	90 in 1 BOTTLE	TABLET, FILM COATED	90	101
71335-1230-3	Etodolac	30 in 1 BOTTLE	TABLET, FILM COATED	30	101
71335-1230-4	Etodolac	100 in 1 BOTTLE	TABLET, FILM COATED	100	101
71335-1230-5	Etodolac	6 in 1 BOTTLE	TABLET, FILM COATED	6	101
71335-1230-6	Etodolac	20 in 1 BOTTLE	TABLET, FILM COATED	20	101
71335-1230-7	Etodolac	14 in 1 BOTTLE	TABLET, FILM COATED	14	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1230	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 7 package rows	20240522_4b0d1245-8d01-4fff-9783-cb30c17d9246.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	55ae2e78-d803-496b-b66d-af1140312785	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	336d5331-4d60-42e2-8cfc-aad57c01eda0	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	00125d63-d8d0-46c5-bdf1-80d2c85eda5a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Northwind Health Company, LLC	b0880f39-a6fa-23ab-e053-2995a90a7eb2	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Northwind Health Company, LLC	da34581d-3066-711c-e053-2995a90a8e84	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	c18497e2-9fca-4500-e053-2a95a90a1bcc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Amneal Pharmaceuticals NY LLC	2f306e69-c109-4e60-aaf3-9016a4e2cc33	2024-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Bryant Ranch Prepack	4b0d1245-8d01-4fff-9783-cb30c17d9246	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 71335-1230
Etodolac	ETODOLAC	Bryant Ranch Prepack	53160db5-ba48-4cac-afbe-acd608daa0dc	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	113558e6-8b45-cdbd-e063-6394a90ac036	2024-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	31a55fb1-9721-4202-af7d-f06074b03102	2023-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Doc Rx	cdde46e5-1123-410f-aafc-0c6e904a5d5b	2021-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834

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	4b0d1245-8d01-4fff-9783-cb30c17d9246	101
199390	etodolac 500 MG Oral Tablet	SCD	4b0d1245-8d01-4fff-9783-cb30c17d9246	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1230-1	71335123001	60 TABLET, FILM COATED in 1 BOTTLE (71335-1230-1)	2019-05-28	0000-00-00	No	No	Current
71335-1230-2	71335123002	90 TABLET, FILM COATED in 1 BOTTLE (71335-1230-2)	2024-05-17	0000-00-00	No	No	Current
71335-1230-3	71335123003	30 TABLET, FILM COATED in 1 BOTTLE (71335-1230-3)	2024-05-17	0000-00-00	No	No	Current
71335-1230-4	71335123004	100 TABLET, FILM COATED in 1 BOTTLE (71335-1230-4)	2024-05-17	0000-00-00	No	No	Current
71335-1230-5	71335123005	6 TABLET, FILM COATED in 1 BOTTLE (71335-1230-5)	2024-05-17	0000-00-00	No	No	Current
71335-1230-6	71335123006	20 TABLET, FILM COATED in 1 BOTTLE (71335-1230-6)	2024-05-17	0000-00-00	No	No	Current
71335-1230-7	71335123007	14 TABLET, FILM COATED in 1 BOTTLE (71335-1230-7)	2024-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Tablets, USP (400 mg and 500 mg) Rx only	Bryant Ranch Prepack	2024-05-17	HUMAN PRESCRIPTION DRUG LABEL	101