Indomethacin

Product NDC: 63629-3201
11-digit product format: 636293201
Labeler code: 63629
Product ID: 63629-3201_c7eb8830-21c0-6e63-3e3a-c13de600faee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091549
Marketing category: ANDA
Marketing start: 2010-12-06
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 75 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3201		D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-5	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-6	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-7	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3201	63629-3201-8	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

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

Historic NDC status page 1 of 2 · 117 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3201-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3201-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3201-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3201-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3201-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3201-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3201-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3201-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3201-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3201-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3201-7	`302b2466d912…`	`e7b80fea0513…`

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
A091549-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091549-001	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	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091549-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-12-01	`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	A091549-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091549-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091549-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091549-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091549-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091549-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091549-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091549-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091549-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091549-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091549-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091549-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091549-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091549-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091549-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091549-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091549-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091549-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091549-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091549-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091549-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091549-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091549-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091549-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091549-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091549-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091549-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091549-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091549-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091549-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091549-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091549-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091549-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091549-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091549-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091549-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091549-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091549-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091549-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091549-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3201-1	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-2	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-3	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-4	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-5	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-6	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-7	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-8	2020-10-12	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-1	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-2	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-3	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-4	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-5	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-6	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-7	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965
63629-3201-8	2020-01-31	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules, for oral use Initial U.S. Approval: 1965

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3201-1	EA - Each	63629-3201	96def891-cf8b-4ad9-be99-2cb28c61633c	1	2012-07-24
63629-3201-2	EA - Each	63629-3201	75b53ee1-e960-4c0c-9e48-57e10ebdc8ee	1	2012-07-24
63629-3201-3	EA - Each	63629-3201	aeb1bc84-a14c-4e3d-ab1f-4d5d57f11c64	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	3

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	Amneal Pharmaceuticals LLC	dbad7e61-2347-43b1-a422-9183e41c10ea	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091549 application number: ANDA091549

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3201-1	63629320101	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-1)	2010-12-06	0000-00-00	No	No	Current
63629-3201-2	63629320102	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-2)	2010-12-06	0000-00-00	No	No	Current
63629-3201-3	63629320103	14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-3)	2010-12-06	0000-00-00	No	No	Current
63629-3201-4	63629320104	10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-4)	2010-12-06	0000-00-00	No	No	Current
63629-3201-5	63629320105	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-5)	2010-12-06	0000-00-00	No	No	Current
63629-3201-6	63629320106	15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-6)	2010-12-06	0000-00-00	No	No	Current
63629-3201-7	63629320107	20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-7)	2010-12-06	0000-00-00	No	No	Current
63629-3201-8	63629320108	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-3201-8)	2010-12-06	0000-00-00	No	No	Current