INDOMETHACIN

Product NDC: 68151-1733
11-digit product format: 681511733
Labeler code: 68151
Product ID: 68151-1733_f68a2ea6-e62f-4a7b-8acb-64ebb0b89e37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA079175
Marketing category: ANDA
Marketing start: 2009-03-06
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: 2018-12-31
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	68151-1733		I	Inactivated by FDA		2026-08-17
excluded package	package	68151-1733	68151-1733-8	I	Inactivated by FDA		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 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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	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	68151-1733-8	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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
A079175-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2009-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079175-001	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 · 42 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	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A079175-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079175-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079175-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079175-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079175-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079175-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079175-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079175-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079175-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079175-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079175-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079175-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079175-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079175-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079175-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079175-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079175-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079175-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079175-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079175-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079175-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079175-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079175-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079175-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079175-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079175-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079175-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079175-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079175-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079175-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079175-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079175-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079175-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079175-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079175-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079175-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079175-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079175-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079175-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079175-001	AB	1	`e64feba35796…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-1733-8	2020-01-31	C162847	48780-1	9d75b9d0-4183-f424-e053-dadaa90a57ce	INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-1733-8	INDOMETHACIN	1 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-1733	INDOMETHACIN CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20160616_429e9731-cc5d-4089-bf4a-81ec22824c9e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INDOMETHACIN	INDOMETHACIN	Bryant Ranch Prepack	41af7776-36bc-4820-b635-e7c69f26997e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175
Indomethacin	INDOMETHACIN	American Health Packaging	5a65b650-ea9b-4d0d-b62f-5971df1e62b4	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175
INDOMETHACIN	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	85014b51-1354-4d16-9995-3ee33a7155fa	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175
INDOMETHACIN	INDOMETHACIN	KVK-Tech, Inc.	dc80228c-acae-44dc-9762-19bd1669bf45	2025-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175

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	429e9731-cc5d-4089-bf4a-81ec22824c9e	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	429e9731-cc5d-4089-bf4a-81ec22824c9e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-1733-8	68151173308	1 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mg Rx Only	Carilion Materials Management	2016-06-16	HUMAN PRESCRIPTION DRUG LABEL	2