Indomethacin

Product NDC: 0378-0143
11-digit product format: 003780143
Labeler code: 0378
Product ID: 0378-0143_1c722370-d051-4f78-8775-1e37c5eda55d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA018858
Marketing category: NDA
Marketing start: 1984-04-20
Marketing end: 2019-07-31
Substance: INDOMETHACIN
Active strength: 25 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-0143		D	Discontinued by firm	2026-08-03
excluded package	package	0378-0143	0378-0143-01	D	Discontinued by firm	2026-08-03
excluded package	package	0378-0143	0378-0143-10	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 · 36 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	0378-0143-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0143-10	`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	0378-0143-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0143-10	`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	0378-0143-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0143-10	`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	0378-0143-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0143-10	`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	0378-0143-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0143-10	`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	0378-0143-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0143-10	`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	0378-0143-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0143-10	`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	0378-0143-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0143-10	`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	0378-0143-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0143-10	`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	0378-0143-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0143-10	`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	0378-0143-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0143-10	`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	0378-0143-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0143-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N018858-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL			1984-04-20
N018858-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL			1984-04-20

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018858-001	INDOMETHACIN	25MG	CAPSULE / ORAL	1984-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018858-002	INDOMETHACIN	50MG	CAPSULE / ORAL	1984-04-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N018858-001	AB	1	`ea99ee380514…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0143-01	EA - Each	0378-0143	ef22332e-136a-459b-be56-10ed5bef9669	1	2012-07-24
0378-0143-10	EA - Each	0378-0143	cf230bfd-d9d4-4f19-bc49-5b92fcb59f44	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2

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
197817	indomethacin 25 MG Oral Capsule	PSN	58ae8e0c-5555-4702-a61f-dde7d396a6db	2
197818	indomethacin 50 MG Oral Capsule	PSN	58ae8e0c-5555-4702-a61f-dde7d396a6db	2
197817	indomethacin 25 MG Oral Capsule	SCD	58ae8e0c-5555-4702-a61f-dde7d396a6db	2
197818	indomethacin 50 MG Oral Capsule	SCD	58ae8e0c-5555-4702-a61f-dde7d396a6db	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2008-03-13	HUMAN PRESCRIPTION DRUG LABEL	2