Etodolac

Product NDC: 50090-2132
Requested package NDC: 50090-2132-1
11-digit product format: 500902132
Labeler code: 50090
Product ID: 50090-2132_d78bfda3-e0f6-44ea-a287-d529aed5fd39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075126
Marketing category: ANDA
Marketing start: 2015-02-01
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: 2027-12-31
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
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 · 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	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…`
2021-12-28 21:50 UTC	2021-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`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	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…`
2021-12-28 21:50 UTC	2021-12	A075126-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075126-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Etodolac
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4d392c1b-95c2-4925-98bf-0203c412d3da	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
50090-2132-1	Etodolac	21 in 1 BOTTLE	CAPSULE	21		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2132-1	EA - Each	50090-2132	93229cf2-60d5-4f46-9292-fac938dc2ce3	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2132	ETODOLAC CAPSULE [A-S MEDICATION SOLUTIONS]	12	Current NDC, Legacy NDC, 1 package rows	20231211_4d392c1b-95c2-4925-98bf-0203c412d3da.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 ndc (package): 50090-2132-1 ndc (product): 50090-2132 ndc11 (package): 50090213201
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	4d392c1b-95c2-4925-98bf-0203c412d3da	14
197685	etodolac 300 MG Oral Capsule	SCD	4d392c1b-95c2-4925-98bf-0203c412d3da	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2132-1	50090213201	21 CAPSULE in 1 BOTTLE (50090-2132-1)	21 capsule	2015-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules USP Rx only	A-S Medication Solutions	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	14