Application 016059

Type: NDA
Sponsor: EGALET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOCIN	INDOMETHACIN	CAPSULE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	INDOCIN	INDOMETHACIN	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N016059-001	INDOCIN	INDOMETHACIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982
N016059-002	INDOCIN	INDOMETHACIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016059-001	INDOCIN	25MG	CAPSULE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016059-002	INDOCIN	50MG	CAPSULE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016059-001	INDOCIN	25MG	CAPSULE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016059-002	INDOCIN	50MG	CAPSULE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982	`782e0a99824c…`

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	bf93022c-a965-49c5-a852-c59e580d7d91	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	205fc4e7-e118-509e-e063-6394a90a78e6	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	009097a5-2c1e-4f5d-8054-896cf896cb3d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	99d7a84b-c755-47be-9d2d-1223162b0a42	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	ce866d3a-7bea-4d82-9b7d-79e8a294c141	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	d66ada00-3ece-4b71-8c59-a0db48a2db80	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	bf11f5a0-f2ee-499a-8d54-9d557cc66841	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	d2997707-1541-4f5d-8c8d-70b0a13be8b2	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals, Inc.	3785c914-0037-49ef-b6f5-a5e868ae490b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	1bb80a9f-def3-4228-ab04-a0c2a117a2b9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Coupler LLC	51266787-b50e-bc15-e063-6394a90ad16f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	6312c9a6-d4d3-eb1f-e053-2991aa0a5e68	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	b4cf01d1-0d71-4f0f-97a5-07a59744149f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	16238287-d4b0-4afa-8483-1f4ae250a625	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Sportpharm LLC	12821a3a-b5f2-4415-84c9-0a30a4725f1e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Bryant Ranch Prepack	41af7776-36bc-4820-b635-e7c69f26997e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	DIRECT RX	7e7175d7-5e43-4151-9702-88ac2cd44ef6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	ANI Pharmaceuticals, Inc.	e8b86758-6cb5-44ac-a5fc-2111e98a19a8	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	RedPharm Drug, Inc.	4d9ef14a-4812-4fcf-e054-00144ff8d46c	2026-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80364	SUPPL	2024-11-25
80363	SUPPL	2024-11-25
80338	SUPPL	2024-11-25
67331	SUPPL	2021-05-03
67330	SUPPL	2021-05-03
67221	SUPPL	2021-04-29
58124	SUPPL	2019-03-28
58089	SUPPL	2019-03-27
58088	SUPPL	2019-03-27
33144	SUPPL	2016-05-11
12969	SUPPL	2016-05-11
10869	SUPPL	2016-05-11
414	SUPPL	2016-05-11
33143	SUPPL	2007-02-02
12968	SUPPL	2007-02-02
33142	SUPPL	2006-01-27
413	SUPPL	2005-03-29