Indomethacin

Product NDC: 50268-432
11-digit product format: 502680432
Labeler code: 50268
Product ID: 50268-432_d5ddb57a-c8e9-4de2-e053-2995a90a58bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: AvPAK
Application: ANDA201807
Marketing category: ANDA
Marketing start: 2015-09-15
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 75 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50268-432		D	Discontinued by firm		2026-08-03
excluded package	package	50268-432	50268-432-15	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

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

Historic NDC status page 1 of 1 · 24 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	50268-432-15	`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	50268-432-15	`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	50268-432-15	`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	50268-432-15	`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	50268-432-15	`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	50268-432-15	`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	50268-432-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50268-432-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50268-432-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50268-432-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50268-432-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50268-432-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

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

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201807-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201807-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-432-11	EA - Each	50268-432	bfed5801-ed01-45d6-b924-e49b9a26f8c4	1	2015-10-02
50268-432-15	EA - Each	50268-432	0b13be86-dc06-4869-a3af-289da4a9ad03	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
POTASSIUM CATION	INACTIVE INGREDIENT	295O53K152	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	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 · 10 matching rows.

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-432-15	50268043215	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-432-15) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-432-11)	50 blister pack	2015-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin Extended-release Capsules, USP Rx Only	AvPAK	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	6