Indomethacin

Product NDC: 21695-522
11-digit product format: 216950522
Labeler code: 21695
Product ID: 21695-522_622ac159-4d19-4c4a-95e2-c3757abf5102
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA091276
Marketing category: ANDA
Marketing start: 2010-12-22
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 25 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-522		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-522	21695-522-21	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-522	21695-522-30	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-522	21695-522-60	I	Inactivated by FDA	2026-10-05

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 · 88 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	21695-522-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-522-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-522-30	`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	21695-522-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-522-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-522-30	`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	21695-522-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-522-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-522-30	`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	21695-522-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-522-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-522-30	`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	21695-522-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-522-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-522-30	`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	21695-522-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-522-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-522-30	`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	21695-522-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-522-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-522-30	`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	21695-522-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-522-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-522-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-522-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-522-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-522-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-522-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-522-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-522-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-522-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-522-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-522-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-522-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-522-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-522-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-522-21	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-522-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-522-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-522-21	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-522-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-522-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-522-21	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-522-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-522-30	`1332a3947898…`	`d4bfe170f9cd…`

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
A091276-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22
A091276-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091276-001	AB
A091276-002	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091276-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091276-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091276-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091276-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091276-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091276-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091276-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091276-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091276-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091276-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091276-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091276-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091276-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091276-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091276-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
234b5275-84d6-d169-e08f-554a8aed3f0a	Product name	3	20250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713b	Product name	2	20250107
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
c6b2f0e9-1a13-02e4-f789-55c724469f07	Product name	7	20171115
6e9718b9-62b9-458f-9408-30d688800922	Product name	1	20171103
d62774ab-b1b9-2d5c-924f-1948e411ae15	Product name	3	20170816
97c70338-ee37-4c78-a047-53ee1cd9b53d	Product name	1	20150616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-522-21	2019-09-24	C162847	48780-1	934fe258-4d82-48b1-e053-8cdaa90a720a	Indomethacin Capsules USP, 25 mg
21695-522-30	2019-09-24	C162847	48780-1	934fe258-4d82-48b1-e053-8cdaa90a720a	Indomethacin Capsules USP, 25 mg
21695-522-60	2019-09-24	C162847	48780-1	934fe258-4d82-48b1-e053-8cdaa90a720a	Indomethacin Capsules USP, 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-522-21	Indomethacin	21 in 1 BOTTLE	CAPSULE	21	2
21695-522-30	Indomethacin	30 in 1 BOTTLE	CAPSULE	30	2
21695-522-60	Indomethacin	60 in 1 BOTTLE	CAPSULE	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-522-21	EA - Each	21695-522	35f96ff0-df8a-45c4-b1f7-2eb174a58483	1	2012-07-24
21695-522-30	EA - Each	21695-522	4f1f0eae-dd18-4294-aa8f-6a3743a91a16	1	2012-07-24
21695-522-60	EA - Each	21695-522	06811f5e-ef93-47e6-a598-d18ff6f46212	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-522	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 3 package rows	20111021_1f60d27b-fa95-40dd-969f-51f977142032.zip

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	Proficient Rx LP	b094eb04-3177-431d-b5ac-edc4804750a2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197817	indomethacin 25 MG Oral Capsule	PSN	1f60d27b-fa95-40dd-969f-51f977142032	2
197817	indomethacin 25 MG Oral Capsule	SCD	1f60d27b-fa95-40dd-969f-51f977142032	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-522-21	21695052221	21 in 1 BOTTLE	Historical
21695-522-30	21695052230	30 in 1 BOTTLE	Historical
21695-522-60	21695052260	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin Capsules USP, 25 mg	Rebel Distributors Corp	2011-05-13	HUMAN PRESCRIPTION DRUG LABEL	2