Indomethacin

Product NDC: 21695-522
11-digit product format: 216950522
Labeler code: 21695
Product ID: 21695-522_622ac159-4d19-4c4a-95e2-c3757abf5102
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
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],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-522		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-522	21695-522-21	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-522	21695-522-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-522	21695-522-60	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
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
21695-522-21	2019-09-24	C162847	48780-1	934fe258-4d82-48b1-e053-8cdaa90a720a	Indomethacin Capsules USP, 25 mg
21695-522-30	2019-09-24	C162847	48780-1	934fe258-4d82-48b1-e053-8cdaa90a720a	Indomethacin Capsules USP, 25 mg
21695-522-60	2019-09-24	C162847	48780-1	934fe258-4d82-48b1-e053-8cdaa90a720a	Indomethacin Capsules USP, 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-522-21	Indomethacin	21 in 1 BOTTLE	CAPSULE	21	2
21695-522-30	Indomethacin	30 in 1 BOTTLE	CAPSULE	30	2
21695-522-60	Indomethacin	60 in 1 BOTTLE	CAPSULE	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-522-21	EA - Each	21695-522	35f96ff0-df8a-45c4-b1f7-2eb174a58483	1	2012-07-24
21695-522-30	EA - Each	21695-522	4f1f0eae-dd18-4294-aa8f-6a3743a91a16	1	2012-07-24
21695-522-60	EA - Each	21695-522	06811f5e-ef93-47e6-a598-d18ff6f46212	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-522	INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 3 package rows	20111021_1f60d27b-fa95-40dd-969f-51f977142032.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	1f60d27b-fa95-40dd-969f-51f977142032	2
197817	indomethacin 25 MG Oral Capsule	SCD	1f60d27b-fa95-40dd-969f-51f977142032	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-522-21	21695052221	21 in 1 BOTTLE	Historical
21695-522-30	21695052230	30 in 1 BOTTLE	Historical
21695-522-60	21695052260	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin Capsules USP, 25 mg	Rebel Distributors Corp	2011-05-13	HUMAN PRESCRIPTION DRUG LABEL	2