Etodolac

Product NDC: 21695-049
11-digit product format: 216950049
Labeler code: 21695
Product ID: 21695-049_db60911a-2bb1-4e8c-baf0-7cf281bf5778
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075126
Marketing category: ANDA
Marketing start: 1999-09-16
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 300 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: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-049		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-049	21695-049-21	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-049	21695-049-30	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-049	21695-049-42	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-049	21695-049-60	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-049	21695-049-90	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 3 · 132 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	21695-049-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-049-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-049-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-049-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-049-60	`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	21695-049-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-049-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-049-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-049-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-049-60	`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	21695-049-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-049-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-049-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-049-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-049-60	`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	21695-049-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-049-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-049-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-049-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-049-60	`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	21695-049-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-049-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-049-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-049-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-049-60	`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	21695-049-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-049-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-049-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-049-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-049-60	`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	21695-049-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-049-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-049-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-049-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-049-60	`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	21695-049-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-049-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-049-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-049-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-049-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-049-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-049-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-049-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-049-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-049-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-049-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-049-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-049-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-049-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-049-60	`ad56d346431e…`	`cc804d4bbf1e…`

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
A075126-001	ETODOLAC	ETODOLAC	200MG	CAPSULE / ORAL	AB		1999-09-16
A075126-002	ETODOLAC	ETODOLAC	300MG	CAPSULE / ORAL	AB		1999-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075126-001	AB
A075126-002	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	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`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	A075126-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075126-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075126-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075126-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075126-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075126-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075126-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075126-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075126-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075126-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075126-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075126-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075126-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075126-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075126-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075126-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075126-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075126-002	AB	1	`bb7c543d1eb4…`

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, Related label table
NDC	Related label
21695-049-21	ETODOLAC CAPSULES USP 8397
21695-049-30	ETODOLAC CAPSULES USP 8397
21695-049-42	ETODOLAC CAPSULES USP 8397
21695-049-60	ETODOLAC CAPSULES USP 8397
21695-049-90	ETODOLAC CAPSULES USP 8397

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-049-21	Etodolac	21 in 1 BOTTLE	CAPSULE, GELATIN COATED	21	1
21695-049-30	Etodolac	30 in 1 BOTTLE	CAPSULE, GELATIN COATED	30	1
21695-049-42	Etodolac	42 in 1 BOTTLE	CAPSULE, GELATIN COATED	42	1
21695-049-60	Etodolac	60 in 1 BOTTLE	CAPSULE, GELATIN COATED	60	1
21695-049-90	Etodolac	90 in 1 BOTTLE	CAPSULE, GELATIN COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-049-21	EA - Each	21695-049	588ebaee-3b7d-425e-b6ab-d107ead6e208	1	2012-07-24
21695-049-30	EA - Each	21695-049	43452b4d-735e-474c-8011-ce70a2f632d7	1	2012-07-24
21695-049-42	EA - Each	21695-049	95190804-2fc4-4894-bb05-214d428a25af	1	2012-07-24
21695-049-60	EA - Each	21695-049	a5fe11c5-23ae-4063-ba83-1f07fdab492c	1	2012-07-24
21695-049-90	EA - Each	21695-049	a0c9a494-be73-4d4b-934d-3ed6cdc49c36	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Etodolac	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
Etodolac	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-049	ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 5 package rows	20110916_db60911a-2bb1-4e8c-baf0-7cf281bf5778.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Bryant Ranch Prepack	301087e4-f05c-4fd3-8815-c86c6f12ff61	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Bryant Ranch Prepack	a355160d-24c3-4a4d-99ea-84c80ce67f90	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Bryant Ranch Prepack	e7a81661-28a2-40d7-8c90-786629c81e36	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	A-S Medication Solutions	4d392c1b-95c2-4925-98bf-0203c412d3da	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	ANI Pharmaceuticals, Inc.	420c7b62-3bea-4d6b-82e0-ab1c176c7f1e	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Bryant Ranch Prepack	b7f7c4a4-6245-43e1-af40-fcf61abbc64e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Bryant Ranch Prepack	dbaa1202-1ade-4471-96fb-4b951b386234	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Proficient Rx LP	0fce1aea-5de2-4acb-8a21-2b775c4adb25	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126

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
197685	etodolac 300 MG Oral Capsule	PSN	db60911a-2bb1-4e8c-baf0-7cf281bf5778	1
197685	etodolac 300 MG Oral Capsule	SCD	db60911a-2bb1-4e8c-baf0-7cf281bf5778	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-049-21	21695004921	21 in 1 BOTTLE	Historical
21695-049-30	21695004930	30 in 1 BOTTLE	Historical
21695-049-42	21695004942	42 in 1 BOTTLE	Historical
21695-049-60	21695004960	60 in 1 BOTTLE	Historical
21695-049-90	21695004990	90 in 1 BOTTLE	Historical