Indomethacin

Product NDC: 43063-930
11-digit product format: 430630930
Labeler code: 43063
Product ID: 43063-930_415e7439-ad47-8b76-e063-6394a90ae24e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA091276
Marketing category: ANDA
Marketing start: 2010-12-22
Substance: INDOMETHACIN
Active strength: 50 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: 2026-12-31
Current FDA listing: Yes

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…`

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 ndc (product): 43063-930
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

Additional Listing Data#

Finished product: Yes
Brand name base: Indomethacin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDOMETHACIN	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XXE1CET956	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197818	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
99d7a84b-c755-47be-9d2d-1223162b0a42	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43063-930-20	Indomethacin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-930-20	EA - Each	43063-930	fa8568dd-ba7d-4dfe-a3b8-b350b6d68afc	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-930	INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20240927_99d7a84b-c755-47be-9d2d-1223162b0a42.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
197818	indomethacin 50 MG Oral Capsule	PSN	99d7a84b-c755-47be-9d2d-1223162b0a42	14
197818	indomethacin 50 MG Oral Capsule	SCD	99d7a84b-c755-47be-9d2d-1223162b0a42	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-930-20	43063093020	20 CAPSULE in 1 BOTTLE, PLASTIC (43063-930-20)	20 capsule	2019-01-09	0000-00-00	No	No	Current