Etodolac

Product NDC: 60505-0040
11-digit product format: 605050040
Labeler code: 60505
Product ID: 60505-0040_41e18dea-7642-9715-53b0-db2b46d8265b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075419
Marketing category: ANDA
Marketing start: 2003-05-01
Substance: ETODOLAC
Active strength: 300 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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Etodolac
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETODOLAC	300 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
197684	Internal RxNorm lookup
197685	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
86c7b7b8-3a98-e5f4-c558-5b5caede6377	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
60505-0040-1	Etodolac	100 in 1 BOTTLE	CAPSULE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0040-1	EA - Each	60505-0040	5d5ae3a8-662f-4def-85e0-f7b92fdecdb6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE [APOTEX CORP.]	2
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE [APOTEX CORP.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ETODOLAC CAPSULE [APOTEX CORP.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ETODOLAC CAPSULE [APOTEX CORP.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ETODOLAC CAPSULE [APOTEX CORP.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC CAPSULE [APOTEX CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC CAPSULE [APOTEX CORP.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ETODOLAC CAPSULE [APOTEX CORP.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ETODOLAC CAPSULE [APOTEX CORP.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ETODOLAC CAPSULE [APOTEX CORP.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC CAPSULE [APOTEX CORP.]	2
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0040	ETODOLAC CAPSULE [APOTEX CORP.]	12	Current NDC, Legacy NDC, 1 package rows	20240809_86c7b7b8-3a98-e5f4-c558-5b5caede6377.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 ndc (product): 60505-0040

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
197684	etodolac 200 MG Oral Capsule	PSN	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	PSN	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	PSN	c2391373-9b5f-4eb9-b595-2439b15d2fbb	13
197684	etodolac 200 MG Oral Capsule	SCD	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	SCD	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	SCD	c2391373-9b5f-4eb9-b595-2439b15d2fbb	13
197685	etodolac 300 MG Oral Capsule	PSN	7ec87ffd-057e-420c-b8f2-0a6eed4152be	4
197685	etodolac 300 MG Oral Capsule	SCD	7ec87ffd-057e-420c-b8f2-0a6eed4152be	4
197685	etodolac 300 MG Oral Capsule	PSN	85b6254b-21da-ea85-e053-2991aa0a7d51	2
197685	etodolac 300 MG Oral Capsule	SCD	85b6254b-21da-ea85-e053-2991aa0a7d51	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0040-1	60505004001	100 CAPSULE in 1 BOTTLE (60505-0040-1)	100 capsule	2003-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules, USP 300 mg Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Etodolac Capsules, USP 200 and 300 mg Rx only	Apotex Corp. \| Apotex Inc.	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	13
Etodolac Capsules, USP	AvKARE	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	5
Etodolac Capsules, USP 200 and 300 mg Rx only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	13
Etodolac Capsules, USP 200 and 300 mg Rx only	NuCare Pharmaceuticals,Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	2