Application 076174

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No
002	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
003	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076174-001	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13
A076174-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13
A076174-003	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076174-001	AB
A076174-002	AB
A076174-003	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 4 · 123 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	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076174-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076174-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076174-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-03-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A076174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076174-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076174-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076174-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076174-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076174-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076174-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076174-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076174-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076174-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076174-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076174-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076174-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076174-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076174-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076174-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076174-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076174-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076174-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076174-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076174-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076174-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076174-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076174-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	TaSun Pharmaceutical Industries, Inc.	2c5b44b4-78d5-43b2-827d-d2763b6672b3	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076174 application number: ANDA076174 ndc (product): 51672-4052 ndc (product): 51672-4053 ndc (product): 51672-4051
Etodolac	ETODOLAC	NORTHSTAR RX LLC	107ea9d7-80a9-41a4-b61e-168370127319	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076174 application number: ANDA076174 ndc (product): 16714-497 ndc (product): 16714-499 ndc (product): 16714-498
Etodolac ER	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	d294d541-3049-6bfe-e053-2995a90a23ea	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076174 application number: ANDA076174 ndc (product): 80425-0181
Etodolac ER	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	baebdfb2-17f6-9081-e053-2a95a90ab331	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076174 application number: ANDA076174 ndc (product): 80425-0126
Etodolac	ETODOLAC	Golden State Medical Supply, Inc.	c59c5108-a09b-2a03-e053-2995a90abba1	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076174 application number: ANDA076174 ndc (product): 60429-315 ndc (product): 60429-313 ndc (product): 60429-314
Etodolac	ETODOLAC	Proficient Rx LP	449b273a-936a-4c49-b0c8-d0daa47733ae	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076174 application number: ANDA076174 ndc (product): 63187-793

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-497	Etodolac	Etodolac	NORTHSTAR RX LLC	ANDA	Current
16714-497	Etodolac	Etodolac	NORTHSTAR RX LLC	ANDA	Current
16714-498	Etodolac	Etodolac	NORTHSTAR RX LLC	ANDA	Current
16714-498	Etodolac	Etodolac	NORTHSTAR RX LLC	ANDA	Current
16714-499	Etodolac	Etodolac	NORTHSTAR RX LLC	ANDA	Current
16714-499	Etodolac	Etodolac	NORTHSTAR RX LLC	ANDA	Current
35356-324	Etodolac	Etodolac	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-1316	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
51672-4051	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4051	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4051	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4051	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4052	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4052	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4052	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4052	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4053	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4053	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4053	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4053	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
60429-313	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-313	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-313	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-313	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-313	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-314	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-314	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-314	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-314	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-314	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-315	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-315	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-315	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-315	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-315	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60760-378	Etodolac	Etodolac	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-793	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63187-793	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63629-4994	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
70518-3116	Etodolac	Etodolac	REMEDYREPACK INC.	ANDA	Current
80425-0126	Lodine XL	Etodolac 600mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0126	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0126	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0126	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0181	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0181	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current