indomethacin

Product NDC: 68462-325
11-digit product format: 684620325
Labeler code: 68462
Product ID: 68462-325_e729f88c-b2c8-4462-98be-7184de95b01d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA203501
Marketing category: ANDA
Marketing start: 2017-06-22
Substance: INDOMETHACIN
Active strength: 75 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203501-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203501-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203501-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-06-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203501-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203501-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203501-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203501-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203501-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203501-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203501-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203501-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203501-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203501-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203501-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203501-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203501-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203501-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203501-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203501-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203501-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203501-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203501-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203501-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203501-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203501-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203501-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203501-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203501-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203501-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203501-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203501-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203501-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203501-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203501-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203501-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203501-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203501-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203501-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203501-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203501-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203501-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203501-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203501-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: indomethacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDOMETHACIN	75 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
310992	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
532d40b2-c05c-4d4f-b7ee-e6434c4c27fc	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	SPL version
68462-325-01	indomethacin	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	13
68462-325-05	indomethacin	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	13
68462-325-10	indomethacin	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	13
68462-325-60	indomethacin	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	13
68462-325-90	indomethacin	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-325-01	EA - Each	68462-325	c398c65c-2e44-46c8-8b5f-dd4d3d01ad4c	1	2017-08-11
68462-325-60	EA - Each	68462-325	e2bd5df7-1ccc-4072-9182-b529f95c1dcc	1	2017-08-11
68462-325-90	EA - Each	68462-325	d5a07646-b456-4a15-ac37-32addbcbef0c	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-325	INDOMETHACIN CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	12	Current NDC, Legacy NDC, 5 package rows	20240104_532d40b2-c05c-4d4f-b7ee-e6434c4c27fc.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
indomethacin	INDOMETHACIN	Glenmark Pharmaceuticals Inc., USA	532d40b2-c05c-4d4f-b7ee-e6434c4c27fc	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203501 application number: ANDA203501 ndc (product): 68462-325

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
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	532d40b2-c05c-4d4f-b7ee-e6434c4c27fc	13
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	532d40b2-c05c-4d4f-b7ee-e6434c4c27fc	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-325-01	68462032501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01)	2017-06-22	0000-00-00	No	No	Current
68462-325-05	68462032505	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05)	2017-06-22	0000-00-00	No	No	Current
68462-325-10	68462032510	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10)	2017-06-22	0000-00-00	No	No	Current
68462-325-60	68462032560	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60)	2017-06-22	0000-00-00	No	No	Current
68462-325-90	68462032590	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90)	2017-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
indomethacin	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	13