Etodolac

Product NDC: 63629-1377
Requested package NDC: 63629-1377-2
11-digit product format: 636291377
Labeler code: 63629
Product ID: 63629-1377_1cd68f58-eeaf-4c6b-8594-a16a8cf0578a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075009
Marketing category: ANDA
Marketing start: 1998-05-20
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 400 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: 2020-12-31
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	63629-1377	63629-1377-2	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
A075009-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL			1997-11-26
A075009-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL			1999-12-28

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	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075009-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075009-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075009-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075009-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075009-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075009-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075009-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075009-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075009-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075009-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1377-1	EA - Each	63629-1377	fc847b71-8c63-44da-82b7-f9a4a3644738	1	2012-07-24
63629-1377-2	EA - Each	63629-1377	c2bce0e9-e206-4c06-a9ee-d55c90608e69	1	2012-07-24
63629-1377-3	EA - Each	63629-1377	c7584ff3-21d6-48cd-999d-92a33fb4fd17	1	2012-07-24
63629-1377-4	EA - Each	63629-1377	66387ec1-6fc0-4537-8d08-7b8f962cb2e2	1	2012-07-24
63629-1377-5	EA - Each	63629-1377	69a9f9ce-1b5b-45c2-82fe-6e18cbdce24d	1	2012-07-24
63629-1377-6	EA - Each	63629-1377	51d132e5-1303-4d12-b748-a5d56f3fcd51	1	2012-07-24
63629-1377-7	EA - Each	63629-1377	e2f1225d-3ff6-4b17-979b-a357395a1361	1	2012-07-24
63629-1377-8	EA - Each	63629-1377	ba76071c-c7a7-4ae8-a1e6-1a53ca6227d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2M36281008	ETODOLAC	41340-25-4	ETODOLAC

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1377-2	63629137702	14 TABLET, FILM COATED in 1 BOTTLE (63629-1377-2)	2005-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETODOLAC TABLETS USP 0892 1893 Rx only	Bryant Ranch Prepack	2019-10-02	HUMAN PRESCRIPTION DRUG LABEL	16