Etodolac

Product NDC: 50090-0613
Requested package NDC: 50090-0613-1
11-digit product format: 500900613
Labeler code: 50090
Product ID: 50090-0613_2fac81ac-3597-47f0-beee-8b9d8181c8d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075419
Marketing category: ANDA
Marketing start: 2003-05-01
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 300 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0613	50090-0613-1	I	Inactivated by FDA		2026-08-03

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075419-001	ETODOLAC	ETODOLAC	200MG	CAPSULE / ORAL	AB		2000-07-28
A075419-002	ETODOLAC	ETODOLAC	300MG	CAPSULE / ORAL	AB		2000-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075419-001	AB
A075419-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075419-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075419-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075419-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075419-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075419-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075419-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075419-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075419-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075419-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075419-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075419-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075419-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075419-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075419-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075419-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075419-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075419-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075419-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075419-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075419-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075419-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075419-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075419-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075419-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075419-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075419-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075419-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075419-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075419-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075419-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075419-002	AB	1	`782e0a99824c…`

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
50090-0613-0	2023-01-30	C162847	48780-1	f386c649-bec3-0266-e053-dadaa90a7c1a	Etodolac Capsules, USP 200 and 300 mg Rx only
50090-0613-1	2023-01-30	C162847	48780-1	f386c649-bec3-0266-e053-dadaa90a7c1a	Etodolac Capsules, USP 200 and 300 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0613-0	Etodolac	30 in 1 BOTTLE	CAPSULE	30		13
50090-0613-1	Etodolac	21 in 1 BOTTLE	CAPSULE	21		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0613-1	EA - Each	50090-0613	9a8b0110-4968-432a-b22c-b557fe9ff061	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0613	ETODOLAC CAPSULE [A-S MEDICATION SOLUTIONS]	13	Legacy NDC, 2 package rows	20210616_c2391373-9b5f-4eb9-b595-2439b15d2fbb.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	Northwind Health Company, LLC	7ec87ffd-057e-420c-b8f2-0a6eed4152be	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075419 application number: ANDA075419
Etodolac	ETODOLAC	Apotex Corp.	86c7b7b8-3a98-e5f4-c558-5b5caede6377	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075419 application number: ANDA075419

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	c2391373-9b5f-4eb9-b595-2439b15d2fbb	13
197685	etodolac 300 MG Oral Capsule	SCD	c2391373-9b5f-4eb9-b595-2439b15d2fbb	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0613-1	50090061301	21 CAPSULE in 1 BOTTLE (50090-0613-1)	21 capsule	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules, USP 200 and 300 mg Rx only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	13