Indomethacin

Product NDC: 71335-0992
11-digit product format: 713350992
Labeler code: 71335
Product ID: 71335-0992_d3d7cb69-1bcd-44b0-92b8-74c48abc60bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091240
Marketing category: ANDA
Marketing start: 2016-05-19
Substance: INDOMETHACIN
Active strength: 25 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0992		D	Discontinued by firm	2026-08-03
excluded package	package	71335-0992	71335-0992-1	D	Discontinued by firm	2026-08-03
excluded package	package	71335-0992	71335-0992-2	D	Discontinued by firm	2026-08-03
excluded package	package	71335-0992	71335-0992-3	D	Discontinued by firm	2026-08-03
excluded package	package	71335-0992	71335-0992-4	D	Discontinued by firm	2026-08-03
excluded package	package	71335-0992	71335-0992-5	D	Discontinued by firm	2026-08-03

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 · 72 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	71335-0992-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0992-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0992-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0992-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0992-1	`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	71335-0992-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0992-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0992-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0992-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0992-1	`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	71335-0992-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0992-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0992-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0992-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0992-1	`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	71335-0992-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0992-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0992-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0992-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0992-1	`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	71335-0992-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0992-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0992-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0992-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0992-1	`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	71335-0992-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0992-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0992-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0992-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0992-1	`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	71335-0992-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0992-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0992-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0992-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0992-1	`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	71335-0992-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0992-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0992-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0992-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0992-1	`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	71335-0992-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0992-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0992-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0992-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0992-1	`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	71335-0992-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0992-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0992-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0992-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0992-1	`ad56d346431e…`	`cc804d4bbf1e…`

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
A091240-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2011-04-12
A091240-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2011-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091240-001	AB
A091240-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091240-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091240-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091240-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091240-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091240-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091240-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Indomethacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDOMETHACIN	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XXE1CET956	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197817	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	Available on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0992-1	Indomethacin	20 in 1 BOTTLE	CAPSULE	20	103
71335-0992-2	Indomethacin	30 in 1 BOTTLE	CAPSULE	30	103
71335-0992-3	Indomethacin	60 in 1 BOTTLE	CAPSULE	60	103
71335-0992-4	Indomethacin	90 in 1 BOTTLE	CAPSULE	90	103
71335-0992-5	Indomethacin	21 in 1 BOTTLE	CAPSULE	21	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0992	INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 5 package rows	20250331_b1bb9349-21e4-4e6a-9916-3aac6c4d01b8.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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	205fc4e7-e118-509e-e063-6394a90a78e6	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	ce866d3a-7bea-4d82-9b7d-79e8a294c141	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	d66ada00-3ece-4b71-8c59-a0db48a2db80	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	A-S Medication Solutions	d2997707-1541-4f5d-8c8d-70b0a13be8b2	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals, Inc.	3785c914-0037-49ef-b6f5-a5e868ae490b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
INDOMETHACIN	INDOMETHACIN	DIRECT RX	7e7175d7-5e43-4151-9702-88ac2cd44ef6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	dffe9b95-3cb6-4c4e-e053-2a95a90a9328	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	971c4d53-7876-4f42-ba2d-c391714fa341	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	A-S Medication Solutions	5b05b8bc-4df0-4175-bf53-72129fb21b50	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	a329976b-4a01-42ea-a666-0ac99ed2522e	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	1ce9c3c5-0cf7-4760-988d-2559adcfb200	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	67b16cf2-e24c-4fe3-8d74-e63549b7659f	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240 ndc (product): 71335-0992
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	2f4a5796-5317-4caa-83e4-0595fe844df4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	AvPAK	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9236d783-d7b8-4486-94c6-5ecd876bc475	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	56e19868-3973-4f1b-b80f-1f7daf1f1c22	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	afbb24fd-3695-4a30-a8a6-36239e35a14f	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240

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	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	103
197817	indomethacin 25 MG Oral Capsule	SCD	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0992-1	71335099201	20 CAPSULE in 1 BOTTLE (71335-0992-1)	20 capsule	2022-02-09	0000-00-00	No	No	Current
71335-0992-2	71335099202	30 CAPSULE in 1 BOTTLE (71335-0992-2)	30 capsule	2022-02-09	0000-00-00	No	No	Current
71335-0992-3	71335099203	60 CAPSULE in 1 BOTTLE (71335-0992-3)	60 capsule	2022-02-09	0000-00-00	No	No	Current
71335-0992-4	71335099204	90 CAPSULE in 1 BOTTLE (71335-0992-4)	90 capsule	2022-02-09	0000-00-00	No	No	Current
71335-0992-5	71335099205	21 CAPSULE in 1 BOTTLE (71335-0992-5)	21 capsule	2022-02-09	0000-00-00	No	No	Current