indomethacin

Product NDC: 63187-852
11-digit product format: 631870852
Labeler code: 63187
Product ID: 63187-852_03ae31de-621b-4ccc-8c25-17a53f124176
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090403
Marketing category: ANDA
Marketing start: 2016-07-21
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 25 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: 2020-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-852		D	Discontinued by firm	2026-08-03
excluded package	package	63187-852	63187-852-08	D	Discontinued by firm	2026-08-03
excluded package	package	63187-852	63187-852-15	D	Discontinued by firm	2026-08-03
excluded package	package	63187-852	63187-852-20	D	Discontinued by firm	2026-08-03
excluded package	package	63187-852	63187-852-30	D	Discontinued by firm	2026-08-03
excluded package	package	63187-852	63187-852-60	D	Discontinued by firm	2026-08-03
excluded package	package	63187-852	63187-852-90	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 · 14 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	63187-852-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-852-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-852-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-852-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-852-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-852-30	`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	63187-852-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-852-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-852-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-852-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-852-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-852-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090403-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-11-15
A090403-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2010-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090403-001	AB
A090403-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090403-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090403-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090403-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090403-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090403-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090403-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090403-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090403-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090403-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090403-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090403-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090403-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090403-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090403-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090403-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090403-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090403-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090403-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-852-30	EA - Each	63187-852	07241c02-2382-4dce-961c-bad01b199873	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-852	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	3	Legacy NDC	20191113_41d3877f-bc53-4ca5-a4bc-eb3a4bf7f374.zip

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
63187-852-08	63187085208	8 CAPSULE in 1 BOTTLE (63187-852-08)	8 capsule	2016-07-21	0000-00-00	No	No	Current
63187-852-15	63187085215	15 CAPSULE in 1 BOTTLE (63187-852-15)	15 capsule	2016-07-21	0000-00-00	No	No	Current
63187-852-20	63187085220	20 CAPSULE in 1 BOTTLE (63187-852-20)	20 capsule	2016-07-21	0000-00-00	No	No	Current
63187-852-30	63187085230	30 CAPSULE in 1 BOTTLE (63187-852-30)	30 capsule	2016-07-21	0000-00-00	No	No	Current
63187-852-60	63187085260	60 CAPSULE in 1 BOTTLE (63187-852-60)	60 capsule	2017-06-01	0000-00-00	No	No	Current
63187-852-90	63187085290	90 CAPSULE in 1 BOTTLE (63187-852-90)	90 capsule	2017-06-01	0000-00-00	No	No	Current