INDOMETHACIN

Product NDC: 61919-344
11-digit product format: 619190344
Labeler code: 61919
Product ID: 61919-344_b63acc57-8efe-4413-b4c0-ff35a197c733
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: INDOMETHACIN
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Direct RX
Application: ANDA201807
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 75 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-344		I	Inactivated by FDA		2026-08-03
excluded package	package	61919-344	61919-344-60	I	Inactivated by FDA		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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-344-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-344-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-344-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-344-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-344-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-344-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-344-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-344-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-344-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-344-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-344-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-344-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-344-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-344-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-344-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-344-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-344-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-344-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-344-60	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-344-60	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-344-60	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-344-60	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201807-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201807-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201807-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
234b5275-84d6-d169-e08f-554a8aed3f0a	Product name	3	20250717
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1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
9aaf7cf4-60c3-b44f-e302-fd8b276c713b	Product name	2	20250107
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
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362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
97c70338-ee37-4c78-a047-53ee1cd9b53d	Product name	1	20150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-344-60	2020-01-31	C162847	48780-1	9d75b9d0-4627-f424-e053-dadaa90a57ce	INDOMETHACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-344-60	INDOMETHACIN	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
POTASSIUM CATION	INACTIVE INGREDIENT	295O53K152	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-344	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1	Legacy NDC, 1 package rows	20150702_ef9444e9-fc20-4139-ae74-ae9268e44a21.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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Sportpharm LLC	12821a3a-b5f2-4415-84c9-0a30a4725f1e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	f2f59f63-fcda-2a80-e053-2995a90ab087	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	efa111d5-ade4-4944-97e4-3c37b8b14ea8	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	12f62bae-5fc0-4f8d-a8b4-446524bd53d1	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	d54d6e12-e827-4248-819a-de76afa70371	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin ER	INDOMETHACIN	Advanced Rx Pharmacy of Tennessee, LLC	f4e8a719-ef9c-a2ef-e053-2995a90ad788	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	c6126527-5272-4477-8716-d05365a05225	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Proficient Rx LP	ac458b4b-95bb-4235-a447-e8c4ba720257	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807

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
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	ef9444e9-fc20-4139-ae74-ae9268e44a21	1
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	ef9444e9-fc20-4139-ae74-ae9268e44a21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-344-60	61919034460	60 in 1 BOTTLE	Historical