Etodolac

Product NDC: 60505-0102
11-digit product format: 605050102
Labeler code: 60505
Product ID: 60505-0102_2da02bc5-af97-2998-e639-79e3197375b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA076004
Marketing category: ANDA
Marketing start: 2003-05-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-0102	60505-0102-2	D	Discontinued by firm		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 · 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 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
A076004-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2002-12-03
A076004-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2002-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076004-001	AB
A076004-002	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	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`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	A076004-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076004-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076004-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076004-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076004-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076004-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076004-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076004-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076004-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076004-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076004-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076004-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076004-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076004-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076004-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076004-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076004-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076004-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197686	Internal RxNorm lookup
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
4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-0102-1	Etodolac	100 in 1 BOTTLE	TABLET, FILM COATED	100		16
60505-0102-2	Etodolac	500 in 1 BOTTLE	TABLET, FILM COATED	500		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0102-1	EA - Each	60505-0102	4b45057f-ad61-4cd5-9d3c-dbc1ec0f2c10	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 [APOTEX CORP.]	5
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Povidone	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0102	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	15	Current NDC, Legacy NDC, 2 package rows	20240809_4d682f98-1e8a-4c2b-6df3-169d2ed10dc1.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	St. Marys Medical Park Pharmacy	60cb4de0-ed88-a46b-e053-2a91aa0a8b6d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	REMEDYREPACK INC.	cad9b5ca-a9d4-41d4-aff2-67d0c458aad6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	007c55fa-ef8b-4a8e-bfe5-e47c6e5da727	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	41bd86b9-2ef3-49a4-874e-fe8ac6891080	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	556eaa67-d30d-4095-a981-c65f98d3acdd	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	REMEDYREPACK INC.	1a38815e-1903-4f03-b83e-9780c71d4971	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	80e9d756-9278-48bb-bfdd-7d070ae0f341	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Bryant Ranch Prepack	479bce92-2066-46ed-b4bb-8c7a59edfffd	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Apotex Corp.	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004 ndc (product): 60505-0102
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	556a7d5f-2c3c-4efb-ac0c-fca140791602	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	d83d9f30-c367-f8b3-e053-2a95a90a1f40	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Bryant Ranch Prepack	be53bc5c-4294-44a7-b28c-7db3f925396d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	141be3f6-198d-ce46-e063-6294a90a7993	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Medsource Pharmaceuticals	12f0685b-2127-d0d6-e063-6394a90a62d1	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Proficient Rx LP	e2fef939-2f4a-46ae-8177-073f5e8f57f5	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	A-S Medication Solutions	74baa6ad-b517-48e2-8cef-d77f5755b279	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Proficient Rx LP	0c783997-6f2a-45ae-b899-c060c8be468a	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004

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	41bd86b9-2ef3-49a4-874e-fe8ac6891080	18
199390	etodolac 500 MG Oral Tablet	SCD	41bd86b9-2ef3-49a4-874e-fe8ac6891080	18
197686	etodolac 400 MG Oral Tablet	PSN	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	16
199390	etodolac 500 MG Oral Tablet	PSN	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	16
197686	etodolac 400 MG Oral Tablet	SCD	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	16
199390	etodolac 500 MG Oral Tablet	SCD	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	16
197686	etodolac 400 MG Oral Tablet	PSN	be53bc5c-4294-44a7-b28c-7db3f925396d	12
199390	etodolac 500 MG Oral Tablet	PSN	be53bc5c-4294-44a7-b28c-7db3f925396d	12
197686	etodolac 400 MG Oral Tablet	SCD	be53bc5c-4294-44a7-b28c-7db3f925396d	12
199390	etodolac 500 MG Oral Tablet	SCD	be53bc5c-4294-44a7-b28c-7db3f925396d	12
199390	etodolac 500 MG Oral Tablet	PSN	cad9b5ca-a9d4-41d4-aff2-67d0c458aad6	5
199390	etodolac 500 MG Oral Tablet	SCD	cad9b5ca-a9d4-41d4-aff2-67d0c458aad6	5
199390	etodolac 500 MG Oral Tablet	PSN	0c783997-6f2a-45ae-b899-c060c8be468a	2
199390	etodolac 500 MG Oral Tablet	PSN	490cc21d-70a5-634b-e054-00144ff8d46c	2
199390	etodolac 500 MG Oral Tablet	SCD	490cc21d-70a5-634b-e054-00144ff8d46c	2
199390	etodolac 500 MG Oral Tablet	SCD	0c783997-6f2a-45ae-b899-c060c8be468a	2
199390	etodolac 500 MG Oral Tablet	PSN	12f0685b-2127-d0d6-e063-6394a90a62d1	1
199390	etodolac 500 MG Oral Tablet	PSN	cf666a19-03e5-4172-952e-2672557a7431	1
199390	etodolac 500 MG Oral Tablet	SCD	12f0685b-2127-d0d6-e063-6394a90a62d1	1
199390	etodolac 500 MG Oral Tablet	SCD	cf666a19-03e5-4172-952e-2672557a7431	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0102-1	60505010201	100 TABLET, FILM COATED in 1 BOTTLE (60505-0102-1)	2003-05-01	0000-00-00	No	No	Current
60505-0102-2	60505010202	500 TABLET, FILM COATED in 1 BOTTLE (60505-0102-2)	2003-05-01	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	REMEDYREPACK INC.	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	6
ETODOLAC TABLETS, USP 500 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	18
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Apotex Corp. \| Apotex Inc.	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	16
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Bryant Ranch Prepack	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	12
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Medsource Pharmaceuticals \| Apotex Inc.	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	1
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	A-S Medication Solutions	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL	27
ETODOLAC TABLETS, USP 500 mg Rx only	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Quality Care Products, LLC	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	3
ETODOLAC	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Preferred Pharmaceuticals Inc.	2019-09-16	HUMAN PRESCRIPTION DRUG LABEL	3
ETODOLAC	DIRECT RX	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	3
ETODOLAC TABLETS, USP 500 mg Rx only	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-21	HUMAN PRESCRIPTION DRUG LABEL	1