INDOMETHACIN ER

Product NDC: 12634-160
11-digit product format: 126340160
Labeler code: 12634
Product ID: 12634-160_543aa8e5-219e-41d8-8ffa-9ae1446d3391
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: INDOMETHACIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotheca, Inc.
Application: ANDA079175
Marketing category: ANDA
Marketing start: 2010-03-04
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 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-160		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-25	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-55	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-160	12634-160-97	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 6 · 330 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	12634-160-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-160-57	`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	12634-160-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-160-57	`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	12634-160-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-97	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-160-57	`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	12634-160-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-97	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-84	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-160-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
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
12634-160-00	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-25	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-54	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-55	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-57	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-59	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-60	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-71	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-79	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-80	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-84	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-85	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-91	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-97	INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-160-00	INDOMETHACIN ER	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	2
12634-160-25	INDOMETHACIN ER	25 in 1 BLISTER PACK	CAPSULE	25	2
12634-160-54	INDOMETHACIN ER	14 in 1 BLISTER PACK	CAPSULE	14	2
12634-160-55	INDOMETHACIN ER	15 in 1 BLISTER PACK	CAPSULE	15	2
12634-160-57	INDOMETHACIN ER	20 in 1 BLISTER PACK	CAPSULE	20	2
12634-160-59	INDOMETHACIN ER	30 in 1 BLISTER PACK	CAPSULE	30	2
12634-160-60	INDOMETHACIN ER	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	2
12634-160-71	INDOMETHACIN ER	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	2
12634-160-79	INDOMETHACIN ER	25 in 1 BOTTLE, PLASTIC	CAPSULE	25	2
12634-160-80	INDOMETHACIN ER	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	2
12634-160-84	INDOMETHACIN ER	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	2
12634-160-85	INDOMETHACIN ER	15 in 1 BOTTLE, PLASTIC	CAPSULE	15	2
12634-160-91	INDOMETHACIN ER	1 in 1 BLISTER PACK	CAPSULE	1	2
12634-160-97	INDOMETHACIN ER	7 in 1 BOTTLE, PLASTIC	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
12634-160	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2	Legacy NDC, 14 package rows	20100419_6569dfd1-0164-4241-b508-ccd540d1e858.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	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
12634-160-00	12634016000	10 in 1 BOTTLE, PLASTIC	Historical
12634-160-25	12634016025	25 in 1 BLISTER PACK	Historical
12634-160-54	12634016054	14 in 1 BLISTER PACK	Historical
12634-160-55	12634016055	15 in 1 BLISTER PACK	Historical
12634-160-57	12634016057	20 in 1 BLISTER PACK	Historical
12634-160-59	12634016059	30 in 1 BLISTER PACK	Historical
12634-160-60	12634016060	60 in 1 BOTTLE, PLASTIC	Historical
12634-160-71	12634016071	30 in 1 BOTTLE, PLASTIC	Historical
12634-160-79	12634016079	25 in 1 BOTTLE, PLASTIC	Historical
12634-160-80	12634016080	20 in 1 BOTTLE, PLASTIC	Historical
12634-160-84	12634016084	14 in 1 BOTTLE, PLASTIC	Historical
12634-160-85	12634016085	15 in 1 BOTTLE, PLASTIC	Historical
12634-160-91	12634016091	1 in 1 BLISTER PACK	Historical
12634-160-97	12634016097	7 in 1 BOTTLE, PLASTIC	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