Indomethacin

Product NDC: 65977-5043
11-digit product format: 659775043
Labeler code: 65977
Product ID: 65977-5043_110aada7-dfe8-4ecf-80c7-4dac8907ad29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Hetero Drugs Ltd.,
Application: ANDA091240
Marketing category: ANDA
Marketing start: 2011-04-12
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 50 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65977-5043		I	Inactivated by FDA	2026-07-31
excluded package	package	65977-5043	65977-5043-0	I	Inactivated by FDA	2026-07-31
excluded package	package	65977-5043	65977-5043-1	I	Inactivated by FDA	2026-07-31
excluded package	package	65977-5043	65977-5043-2	I	Inactivated by FDA	2026-07-31
excluded package	package	65977-5043	65977-5043-3	I	Inactivated by FDA	2026-07-31

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
A091240-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2011-04-12
A091240-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2011-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091240-001	AB
A091240-002	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	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2011-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2011-04-12	`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	A091240-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091240-002	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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	205fc4e7-e118-509e-e063-6394a90a78e6	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	ce866d3a-7bea-4d82-9b7d-79e8a294c141	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	d66ada00-3ece-4b71-8c59-a0db48a2db80	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	A-S Medication Solutions	d2997707-1541-4f5d-8c8d-70b0a13be8b2	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals, Inc.	3785c914-0037-49ef-b6f5-a5e868ae490b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
INDOMETHACIN	INDOMETHACIN	DIRECT RX	7e7175d7-5e43-4151-9702-88ac2cd44ef6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	dffe9b95-3cb6-4c4e-e053-2a95a90a9328	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	971c4d53-7876-4f42-ba2d-c391714fa341	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	A-S Medication Solutions	5b05b8bc-4df0-4175-bf53-72129fb21b50	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	a329976b-4a01-42ea-a666-0ac99ed2522e	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	1ce9c3c5-0cf7-4760-988d-2559adcfb200	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	67b16cf2-e24c-4fe3-8d74-e63549b7659f	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	2f4a5796-5317-4caa-83e4-0595fe844df4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	AvPAK	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9236d783-d7b8-4486-94c6-5ecd876bc475	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	56e19868-3973-4f1b-b80f-1f7daf1f1c22	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	afbb24fd-3695-4a30-a8a6-36239e35a14f	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65977-5043-0	2019-10-29	C162847	48780-1	960f7f55-d18d-8e05-e053-dbdaa90a074a	110aada7-dfe8-4ecf-80c7-4dac8907ad29
65977-5043-1	2019-10-29	C162847	48780-1	960f7f55-d18d-8e05-e053-dbdaa90a074a	110aada7-dfe8-4ecf-80c7-4dac8907ad29
65977-5043-2	2019-10-29	C162847	48780-1	960f7f55-d18d-8e05-e053-dbdaa90a074a	110aada7-dfe8-4ecf-80c7-4dac8907ad29
65977-5043-3	2019-10-29	C162847	48780-1	960f7f55-d18d-8e05-e053-dbdaa90a074a	110aada7-dfe8-4ecf-80c7-4dac8907ad29

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65977-5043-0	Indomethacin	30 in 1 BOTTLE	CAPSULE	30	1
65977-5043-1	Indomethacin	100 in 1 BOTTLE	CAPSULE	100	1
65977-5043-2	Indomethacin	500 in 1 BOTTLE	CAPSULE	500	1
65977-5043-3	Indomethacin	1000 in 1 BOTTLE	CAPSULE	1000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65977-5043	INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,]	1	Legacy NDC, 4 package rows	20110512_110aada7-dfe8-4ecf-80c7-4dac8907ad29.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	110aada7-dfe8-4ecf-80c7-4dac8907ad29	1
197818	indomethacin 50 MG Oral Capsule	PSN	110aada7-dfe8-4ecf-80c7-4dac8907ad29	1
197817	indomethacin 25 MG Oral Capsule	SCD	110aada7-dfe8-4ecf-80c7-4dac8907ad29	1
197818	indomethacin 50 MG Oral Capsule	SCD	110aada7-dfe8-4ecf-80c7-4dac8907ad29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65977-5043-0	65977504300	30 in 1 BOTTLE	Historical
65977-5043-1	65977504301	100 in 1 BOTTLE	Historical
65977-5043-2	65977504302	500 in 1 BOTTLE	Historical
65977-5043-3	65977504303	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin - Hetero Drugs Ltd., \| Hetero Drugs Limited	Hetero Drugs Ltd., \| Hetero Drugs Limited	2011-05-04	Human Prescription Drug Label	1