Indomethacin

Product NDC: 63629-1418
11-digit product format: 636291418
Labeler code: 63629
Product ID: 63629-1418_830c264c-75bf-413c-acee-9508586e82f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA018851
Marketing category: NDA
Marketing start: 2010-07-30
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 50 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-1418		D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-5	D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-6	D	Discontinued by firm	2026-08-17
excluded package	package	63629-1418	63629-1418-7	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 104 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1418-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1418-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1418-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1418-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1418-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1418-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1418-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1418-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1418-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1418-6	`ed331223b511…`	`672a5bd82f5f…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-1418-1	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-2	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-3	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-4	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-5	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-6	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-7	2020-06-20	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-1	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-2	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-3	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-4	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-5	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-6	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
63629-1418-7	2020-01-31	Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1418-1	EA - Each	63629-1418	a3ff5801-06d3-41fb-ab8e-f348abf7f996	1	2012-07-24
63629-1418-2	EA - Each	63629-1418	cd60aafb-30a6-4b4b-a632-0262783d7073	1	2012-07-24
63629-1418-3	EA - Each	63629-1418	f2d40990-c013-49e8-a760-97efa0ad67e0	1	2012-07-24
63629-1418-4	EA - Each	63629-1418	4b324c22-2575-43e5-b37c-b430af4346a6	1	2012-07-24
63629-1418-5	EA - Each	63629-1418	70e3146c-af81-49fe-8dd6-1cba872bd1da	1	2012-07-24
63629-1418-6	EA - Each	63629-1418	ab5d502f-bf5f-4e7d-b781-2ce059ae12db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XXE1CET956	INDOMETHACIN	53-86-1	INDOMETHACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1418-1	63629141801	21 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-1)	21 capsule	2010-07-30	0000-00-00	No	No	Current
63629-1418-2	63629141802	42 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-2)	42 capsule	2010-07-30	0000-00-00	No	No	Current
63629-1418-3	63629141803	30 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-3)	30 capsule	2010-07-30	0000-00-00	No	No	Current
63629-1418-4	63629141804	60 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-4)	60 capsule	2010-07-30	0000-00-00	No	No	Current
63629-1418-5	63629141805	90 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-5)	90 capsule	2010-07-30	0000-00-00	No	No	Current
63629-1418-6	63629141806	14 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-6)	14 capsule	2010-07-30	0000-00-00	No	No	Current
63629-1418-7	63629141807	20 CAPSULE in 1 BOTTLE, PLASTIC (63629-1418-7)	20 capsule	2010-07-30	0000-00-00	No	No	Current