Application 018851

Type: NDA
Sponsor: HERITAGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN	INDOMETHACIN	CAPSULE;ORAL	25MG	No	No
002	INDOMETHACIN	INDOMETHACIN	CAPSULE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018851-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL			1984-05-18
N018851-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL			1984-05-18

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 · 84 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
2026-08-18 06:07:40	2026-07	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	1984-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	1984-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018851-001	INDOMETHACIN	25MG	CAPSULE / ORAL		1984-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018851-002	INDOMETHACIN	50MG	CAPSULE / ORAL		1984-05-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018851-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018851-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N018851-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018851-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018851-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018851-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018851-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018851-002	AB	1	`ea99ee380514…`

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	A-S Medication Solutions	d2997707-1541-4f5d-8c8d-70b0a13be8b2	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	bf93022c-a965-49c5-a852-c59e580d7d91	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin 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 brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	009097a5-2c1e-4f5d-8054-896cf896cb3d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	99d7a84b-c755-47be-9d2d-1223162b0a42	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	ce866d3a-7bea-4d82-9b7d-79e8a294c141	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	d66ada00-3ece-4b71-8c59-a0db48a2db80	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	bf11f5a0-f2ee-499a-8d54-9d557cc66841	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals, Inc.	3785c914-0037-49ef-b6f5-a5e868ae490b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	1bb80a9f-def3-4228-ab04-a0c2a117a2b9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Coupler LLC	51266787-b50e-bc15-e063-6394a90ad16f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin 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 brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	b4cf01d1-0d71-4f0f-97a5-07a59744149f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	16238287-d4b0-4afa-8483-1f4ae250a625	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Sportpharm LLC	12821a3a-b5f2-4415-84c9-0a30a4725f1e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Bryant Ranch Prepack	41af7776-36bc-4820-b635-e7c69f26997e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	DIRECT RX	7e7175d7-5e43-4151-9702-88ac2cd44ef6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	ANI Pharmaceuticals, Inc.	e8b86758-6cb5-44ac-a5fc-2111e98a19a8	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	RedPharm Drug, Inc.	4d9ef14a-4812-4fcf-e054-00144ff8d46c	2026-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-010	Indomethacin	Indomethacin	Heritage Pharmaceuticals Inc.	NDA	Current
23155-011	Indomethacin	Indomethacin	Heritage Pharmaceuticals Inc.	NDA	Current
42254-237	INDOMETHACIN	indomethacin	Rebel Distributors Corp	ANDA	Current
43063-594	Indomethacin	Indomethacin	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-594	Indomethacin	Indomethacin	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55700-378	Indomethacin	Indomethacin	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
61919-487	INDOMETHACIN	INDOMETHACIN	DirectRX	NDA	Current
61919-985	INDOMETHACIN	INDOMETHACIN	DIRECT RX	NDA	Current
61919-985	INDOMETHACIN	INDOMETHACIN	DIRECT RX	NDA	Current
63187-290	INDOMETHACIN	indomethacin	Proficient Rx LP	NDA	Current
63187-697	INDOMETHACIN	indomethacin	Proficient Rx LP	NDA	Current
63629-1418	Indomethacin	Indomethacin	Bryant Ranch Prepack	NDA	Current
63629-1418	Indomethacin	Indomethacin	Bryant Ranch Prepack	NDA	Current
63629-1418	Indomethacin	Indomethacin	Bryant Ranch Prepack	NDA	Current
63629-1780	Indomethacin	Indomethacin	Bryant Ranch Prepack	NDA	Current
63629-1780	Indomethacin	Indomethacin	Bryant Ranch Prepack	NDA	Current
67296-0560	Indomethacin	Indomethacin	RedPharm Drug Inc.	ANDA	Current
67296-1008	Indomethacin	Indomethacin	RedPharm Drug, Inc.	NDA	Current
67296-1008	Indomethacin	Indomethacin	RedPharm Drug, Inc.	NDA	Current
67296-1107	Indomethacin	Indomethacin	RedPharm Drug, Inc.	NDA	Current
67296-1107	Indomethacin	Indomethacin	RedPharm Drug, Inc.	NDA	Current
68151-2919	Indomethacin	Indomethacin	Carilion Materials Management	NDA	Current
68788-9107	INDOMETHACIN	indomethacin	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9108	INDOMETHACIN	indomethacin	Preferred Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80377	SUPPL	2024-11-25
80376	SUPPL	2024-11-25
80279	SUPPL	2024-11-22
67308	SUPPL	2021-04-30
67306	SUPPL	2021-04-30
67260	SUPPL	2021-04-29
1107	SUPPL	2016-05-12
11352	SUPPL	2016-05-11