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001	INDOCIN	INDOMETHACIN	CAPSULE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	INDOCIN	INDOMETHACIN	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 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
N016059-001	INDOCIN	INDOMETHACIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982
N016059-002	INDOCIN	INDOMETHACIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016059-002	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016059-001	INDOCIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	3e87e34a-6556-4b0f-e054-00144ff8d46c	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	3e8796a6-94c6-0db2-e054-00144ff88e88	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Amneal Pharmaceuticals LLC	dbad7e61-2347-43b1-a422-9183e41c10ea	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	503455d9-471e-554f-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	DIRECT RX	4d9a253a-f014-4fab-e054-00144ff8d46c	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Zydus Lifesciences Limited	c6ca86fb-df23-42c1-9d29-f15312faf60c	2023-08-03		Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	ac458b4b-95bb-4235-a447-e8c4ba720257	2023-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Fresenius Kabi USA, LLC	30e38747-c553-4e2d-bc23-634e1dd90b8d	2023-06-16	Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Fresenius Kabi USA, LLC	dd5caa3f-3c09-4034-bf43-2df80c61c07b	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	XLCare Pharmaceuticals Inc.	bc8a572d-e0e1-4d37-b3c4-b85415d50393	2023-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	66e3205b-eab1-4864-bf36-116e9d79fe3e	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	86c94559-b453-4e61-a76c-6962872f0655	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	b094eb04-3177-431d-b5ac-edc4804750a2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	9c15102c-b6f9-4198-b592-152160591014	2022-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	8aa48212-19b0-4304-9c61-dcf4db2b19ea	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN

Reported adverse events (FAERS/openFDA)#

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

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