etodolac

Product NDC: 50090-8037
Requested package NDC: 50090-8037-1
11-digit product format: 500908037
Labeler code: 50090
Product ID: 50090-8037_a5523ef4-512f-4622-89cb-6951d1fa2aa2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA205448
Marketing category: ANDA
Marketing start: 2026-02-06
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 43.

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
A205448-001	ETODOLAC	ETODOLAC	200MG	CAPSULE / ORAL	AB		2024-08-01
A205448-002	ETODOLAC	ETODOLAC	300MG	CAPSULE / ORAL	AB		2024-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205448-001	AB
A205448-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205448-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2024-08-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205448-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2024-08-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205448-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205448-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205448-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205448-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205448-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205448-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205448-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205448-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205448-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205448-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205448-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205448-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205448-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205448-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205448-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205448-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205448-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205448-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205448-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205448-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205448-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205448-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205448-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205448-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205448-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205448-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205448-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205448-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
1e04a6b7-a671-4999-ab03-aa1a243aac03	Available on FDA.report

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	A-S Medication Solutions	1e04a6b7-a671-4999-ab03-aa1a243aac03	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205448 application number: ANDA205448 ndc (package): 50090-8037-1 ndc (product): 50090-8037 ndc11 (package): 50090803701
etodolac	ETODOLAC	Ipca Laboratories Limited	d583988c-3e7e-4415-b2fd-34049791cd1c	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205448 application number: ANDA205448

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	Units	Marketing start	Sample	Exclude flag	Status
50090-8037-1	50090803701	21 CAPSULE in 1 BOTTLE (50090-8037-1)	21 capsule	2026-08-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules USP Rx only	A-S Medication Solutions	2026-08-28	HUMAN PRESCRIPTION DRUG LABEL	1