INDOMETHACIN

Product NDC: 71335-9754
11-digit product format: 713359754
Labeler code: 71335
Product ID: 71335-9754_6f8b687c-33f2-4936-ac92-aceadb1a90ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA079175
Marketing category: ANDA
Marketing start: 2009-03-06
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: 2027-12-31
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
A079175-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2009-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079175-001	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	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079175-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2009-03-06	`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	A079175-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079175-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079175-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079175-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079175-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079175-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079175-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079175-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079175-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079175-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079175-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079175-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079175-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079175-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079175-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079175-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079175-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079175-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079175-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079175-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079175-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079175-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079175-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079175-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079175-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079175-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079175-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079175-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079175-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079175-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079175-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079175-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079175-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079175-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079175-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079175-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079175-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079175-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079175-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079175-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
41af7776-36bc-4820-b635-e7c69f26997e	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-9754-1	INDOMETHACIN	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	104
71335-9754-2	INDOMETHACIN	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	104
71335-9754-3	INDOMETHACIN	14 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	14	104
71335-9754-4	INDOMETHACIN	10 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	10	104
71335-9754-5	INDOMETHACIN	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	104
71335-9754-6	INDOMETHACIN	15 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	15	104
71335-9754-7	INDOMETHACIN	20 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	20	104
71335-9754-8	INDOMETHACIN	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	104
71335-9754-9	INDOMETHACIN	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9754	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, 9 package rows	20250519_41af7776-36bc-4820-b635-e7c69f26997e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INDOMETHACIN	INDOMETHACIN	Bryant Ranch Prepack	41af7776-36bc-4820-b635-e7c69f26997e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175 ndc (product): 71335-9754
Indomethacin	INDOMETHACIN	American Health Packaging	5a65b650-ea9b-4d0d-b62f-5971df1e62b4	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175
INDOMETHACIN	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	85014b51-1354-4d16-9995-3ee33a7155fa	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175
INDOMETHACIN	INDOMETHACIN	KVK-Tech, Inc.	dc80228c-acae-44dc-9762-19bd1669bf45	2025-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079175 application number: ANDA079175

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	41af7776-36bc-4820-b635-e7c69f26997e	104
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	41af7776-36bc-4820-b635-e7c69f26997e	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-9754-1	71335975401	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-1)	2023-09-21	No	No	Current
71335-9754-2	71335975402	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-2)	2024-04-09	No	No	Current
71335-9754-3	71335975403	14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-3)	2023-08-01	No	No	Current
71335-9754-4	71335975404	10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-4)	2024-04-09	No	No	Current
71335-9754-5	71335975405	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-5)	2024-04-09	No	No	Current
71335-9754-6	71335975406	15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-6)	2024-04-09	No	No	Current
71335-9754-7	71335975407	20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-7)	2024-04-09	No	No	Current
71335-9754-8	71335975408	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-8)	2024-04-09	No	No	Current
71335-9754-9	71335975409	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-9)	2024-04-09	No	No	Current