Indomethacin

Product NDC: 68151-0279
11-digit product format: 681510279
Labeler code: 68151
Product ID: 68151-0279_94aceca2-4a9e-4203-ba0f-f06978b3e011
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA091276
Marketing category: ANDA
Marketing start: 2010-12-22
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: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	68151-0279		I	Inactivated by FDA		2026-08-03
excluded package	package	68151-0279	68151-0279-1	I	Inactivated by FDA		2026-08-03

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
A091276-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22
A091276-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091276-001	AB
A091276-002	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.

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
2026-08-01 22:54:32	2026-06	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A091276-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091276-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	bf93022c-a965-49c5-a852-c59e580d7d91	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	009097a5-2c1e-4f5d-8054-896cf896cb3d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	99d7a84b-c755-47be-9d2d-1223162b0a42	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	bf11f5a0-f2ee-499a-8d54-9d557cc66841	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	1bb80a9f-def3-4228-ab04-a0c2a117a2b9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Coupler LLC	51266787-b50e-bc15-e063-6394a90ad16f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	6312c9a6-d4d3-eb1f-e053-2991aa0a5e68	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	b4cf01d1-0d71-4f0f-97a5-07a59744149f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	16238287-d4b0-4afa-8483-1f4ae250a625	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	RedPharm Drug, Inc.	4d9ef14a-4812-4fcf-e054-00144ff8d46c	2026-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	A-S Medication Solutions	7755391e-ede3-4a32-854c-736dc6dd2ee3	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	A-S Medication Solutions	927af761-2f37-4e81-a86e-d4fb17cc1897	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	c9f4eda2-5c8f-72eb-e053-2a95a90a06be	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	db0f1127-ebd8-636c-e053-2a95a90a4d44	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Glenmark Pharmaceuticals Inc., USA	f7ed39e2-5431-4e47-935c-c7441d058f94	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	A-S Medication Solutions	175a2d81-0d0f-46a3-aaaa-1732982d85fd	2024-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9ce37860-407f-47c7-a64c-62b6cc729298	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	503455d9-471e-554f-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
INDOMETHACIN	INDOMETHACIN	DIRECT RX	4d9a253a-f014-4fab-e054-00144ff8d46c	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276
Indomethacin	INDOMETHACIN	Proficient Rx LP	86c94559-b453-4e61-a76c-6962872f0655	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091276 application number: ANDA091276

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-0279-1	2020-01-31	C162847	48780-1	9d75b9d0-c06a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0279-1	Indomethacin	1 in 1 PACKAGE	CAPSULE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0279	INDOMETHACIN CAPSULE [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20180207_00a1272e-a561-4bf4-9a45-a72db19be9dd.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
197817	indomethacin 25 MG Oral Capsule	PSN	00a1272e-a561-4bf4-9a45-a72db19be9dd	2
197817	indomethacin 25 MG Oral Capsule	SCD	00a1272e-a561-4bf4-9a45-a72db19be9dd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-0279-1	68151027901	1 in 1 PACKAGE	Historical