Etodolac

Product NDC: 68151-0738
11-digit product format: 681510738
Labeler code: 68151
Product ID: 68151-0738_44653aa9-6396-4551-b21b-dadf69bb3b58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA075665
Marketing category: ANDA
Marketing start: 2001-02-09
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 400 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-0738		I	Inactivated by FDA		2026-08-17
excluded package	package	68151-0738	68151-0738-0	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-0738-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-0738-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-0738-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-0738-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-0738-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-0738-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-0738-0	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-0738-0	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-0738-0	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-0738-0	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-0738-0	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-0738-0	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-0738-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-0738-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-0738-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-0738-0	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-0738-0	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-0738-0	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-0738-0	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-0738-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-0738-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-0738-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A075665-001	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31
A075665-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31
A075665-003	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075665-001	AB
A075665-002	AB
A075665-003	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 · 126 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	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A075665-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075665-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075665-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075665-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075665-001	AB	1	`1e350fbaab3a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-0738-0	2020-01-31	C162847	48780-1	9d75b9d1-0fc0-f424-e053-dadaa90a57ce	ETODOLAC EXTENDED-RELEASE TABLETS 1122 7172 1118 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0738-0	Etodolac	1 in 1 PACKAGE	TABLET, FILM COATED, EXTENDED RE	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0738	ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_ba27e2db-8036-4b69-ae41-eb200f322ad2.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	Proficient Rx LP	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075665 application number: ANDA075665
Etodolac	ETODOLAC	Teva Pharmaceuticals USA, Inc.	f3bf1675-8fda-40d3-8427-0a6a6133a3d3	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075665 application number: ANDA075665

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
310245	etodolac 400 MG 24HR Extended Release Oral Tablet	PSN	ba27e2db-8036-4b69-ae41-eb200f322ad2	4
310245	24 HR etodolac 400 MG Extended Release Oral Tablet	SCD	ba27e2db-8036-4b69-ae41-eb200f322ad2	4
310245	etodolac 400 MG 24 HR Extended Release Oral Tablet	SY	ba27e2db-8036-4b69-ae41-eb200f322ad2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-0738-0	68151073800	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETODOLAC EXTENDED-RELEASE TABLETS 1122 7172 1118 Rx only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4