INDOMETHACIN ER

Product NDC: 12634-838
11-digit product format: 126340838
Labeler code: 12634
Product ID: 12634-838_543aa8e5-219e-41d8-8ffa-9ae1446d3391
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: INDOMETHACIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotheca, Inc.
Application: ANDA074464
Marketing category: ANDA
Marketing start: 2006-05-02
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 · 20 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-838		I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-00	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-50	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-54	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-55	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-57	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-59	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-60	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-61	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-66	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-67	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-71	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-79	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-80	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-84	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-85	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-90	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-91	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-95	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-838	12634-838-97	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 8 · 440 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	12634-838-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-838-71	`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	12634-838-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-838-71	`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	12634-838-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-97	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-838-71	`2ef7874e63bc…`	`57b86245f4fa…`

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
A074464-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28

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	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL			1998-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074464-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	1998-05-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074464-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074464-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074464-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074464-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074464-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074464-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074464-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074464-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074464-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074464-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074464-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074464-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074464-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A074464-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074464-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074464-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074464-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074464-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074464-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074464-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074464-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074464-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074464-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074464-001	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-838-00	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-50	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-54	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-55	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-57	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-59	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-60	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-61	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-66	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-67	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-71	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-79	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-80	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-84	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-85	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-90	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-91	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-95	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-838-97	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-838-00	INDOMETHACIN ER	10 in 1 BOTTLE	CAPSULE	10	2
12634-838-50	INDOMETHACIN ER	50 in 1 BOTTLE	CAPSULE	50	2
12634-838-54	INDOMETHACIN ER	14 in 1 BLISTER PACK	CAPSULE	14	2
12634-838-55	INDOMETHACIN ER	15 in 1 BLISTER PACK	CAPSULE	15	2
12634-838-57	INDOMETHACIN ER	20 in 1 BLISTER PACK	CAPSULE	20	2
12634-838-59	INDOMETHACIN ER	30 in 1 BLISTER PACK	CAPSULE	30	2
12634-838-60	INDOMETHACIN ER	60 in 1 BOTTLE	CAPSULE	60	2
12634-838-61	INDOMETHACIN ER	10 in 1 BLISTER PACK	CAPSULE	10	2
12634-838-66	INDOMETHACIN ER	6 in 1 BLISTER PACK	CAPSULE	6	2
12634-838-67	INDOMETHACIN ER	7 in 1 BLISTER PACK	CAPSULE	7	2
12634-838-71	INDOMETHACIN ER	30 in 1 BOTTLE	CAPSULE	30	2
12634-838-79	INDOMETHACIN ER	25 in 1 BOTTLE	CAPSULE	25	2
12634-838-80	INDOMETHACIN ER	20 in 1 BOTTLE	CAPSULE	20	2
12634-838-84	INDOMETHACIN ER	14 in 1 BOTTLE	CAPSULE	14	2
12634-838-85	INDOMETHACIN ER	15 in 1 BOTTLE	CAPSULE	15	2
12634-838-90	INDOMETHACIN ER	90 in 1 BOTTLE	CAPSULE	90	2
12634-838-91	INDOMETHACIN ER	1 in 1 BLISTER PACK	CAPSULE	1	2
12634-838-95	INDOMETHACIN ER	5 in 1 BOTTLE	CAPSULE	5	2
12634-838-97	INDOMETHACIN ER	7 in 1 BOTTLE	CAPSULE	7	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-838	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2	Legacy NDC, 19 package rows	20100419_6569dfd1-0164-4241-b508-ccd540d1e858.zip

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	6569dfd1-0164-4241-b508-ccd540d1e858	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	6569dfd1-0164-4241-b508-ccd540d1e858	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-838-00	12634083800	10 in 1 BOTTLE	Historical
12634-838-50	12634083850	50 in 1 BOTTLE	Historical
12634-838-54	12634083854	14 in 1 BLISTER PACK	Historical
12634-838-55	12634083855	15 in 1 BLISTER PACK	Historical
12634-838-57	12634083857	20 in 1 BLISTER PACK	Historical
12634-838-59	12634083859	30 in 1 BLISTER PACK	Historical
12634-838-60	12634083860	60 in 1 BOTTLE	Historical
12634-838-61	12634083861	10 in 1 BLISTER PACK	Historical
12634-838-66	12634083866	6 in 1 BLISTER PACK	Historical
12634-838-67	12634083867	7 in 1 BLISTER PACK	Historical
12634-838-71	12634083871	30 in 1 BOTTLE	Historical
12634-838-79	12634083879	25 in 1 BOTTLE	Historical
12634-838-80	12634083880	20 in 1 BOTTLE	Historical
12634-838-84	12634083884	14 in 1 BOTTLE	Historical
12634-838-85	12634083885	15 in 1 BOTTLE	Historical
12634-838-90	12634083890	90 in 1 BOTTLE	Historical
12634-838-91	12634083891	1 in 1 BLISTER PACK	Historical
12634-838-95	12634083895	5 in 1 BOTTLE	Historical
12634-838-97	12634083897	7 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP	Apotheca, Inc.	2010-04-16	HUMAN PRESCRIPTION DRUG LABEL	2