Indomethacin

Product NDC: 53002-3500
Requested package NDC: 53002-3500-3
11-digit product format: 530023500
Labeler code: 53002
Product ID: 53002-3500_894c9586-d0f9-4a4d-8df4-483e90113203
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA091276
Marketing category: ANDA
Marketing start: 2010-12-22
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 50 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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-3500	53002-3500-3	I	Inactivated by FDA		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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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.

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091276-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091276-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	RS	2010-12-22	`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	A091276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091276-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091276-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091276-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091276-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091276-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091276-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091276-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091276-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091276-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091276-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091276-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091276-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091276-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091276-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091276-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091276-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091276-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091276-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091276-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091276-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091276-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091276-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091276-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091276-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091276-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091276-002	AB	1	`782e0a99824c…`

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, Effective, Related label table
NDC	Effective	Related label
53002-3500-2	2025-01-30	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
53002-3500-3	2025-01-30	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
53002-3500-2	2023-06-08	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
53002-3500-3	2023-06-08	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
53002-3500-2	2023-01-30	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
53002-3500-3	2023-01-30	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
53002-3500-2	2020-12-15	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
53002-3500-3	2020-12-15	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
53002-3500-2	2020-01-31	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
53002-3500-3	2020-01-31	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
53002-3500-2	Indomethacin	20 in 1 BOTTLE	CAPSULE	20		5
53002-3500-3	Indomethacin	30 in 1 BOTTLE	CAPSULE	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3500	INDOMETHACIN CAPSULE [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_da46beba-5693-4c64-b1a8-9ccbe1d38094.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 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

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
197818	indomethacin 50 MG Oral Capsule	PSN	da46beba-5693-4c64-b1a8-9ccbe1d38094	5
197818	indomethacin 50 MG Oral Capsule	SCD	da46beba-5693-4c64-b1a8-9ccbe1d38094	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3500-3	53002350003	30 CAPSULE in 1 BOTTLE (53002-3500-3)	30 capsule	2018-10-01	0000-00-00	No	No	Current