INDOMETHACIN

Product NDC: 10702-016
Requested package NDC: 10702-016-10
11-digit product format: 107020016
Labeler code: 10702
Product ID: 10702-016_30a4fdec-3f89-034c-e063-6294a90aa786
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: KVK-Tech, Inc.
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: 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
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: 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
dc80228c-acae-44dc-9762-19bd1669bf45	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10702-016-01	2024-02-19	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-03	2024-02-19	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-06	2024-02-19	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-09	2024-02-19	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-10	2024-02-19	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-50	2024-02-19	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-01	2024-01-30	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-03	2024-01-30	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-06	2024-01-30	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-09	2024-01-30	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-10	2024-01-30	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-50	2024-01-30	These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10702-016-01	INDOMETHACIN	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	15
10702-016-03	INDOMETHACIN	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	15
10702-016-06	INDOMETHACIN	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	15
10702-016-09	INDOMETHACIN	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	15
10702-016-10	INDOMETHACIN	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	15
10702-016-50	INDOMETHACIN	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-016-01	EA - Each	10702-016	40a06004-7e2d-4de8-ba4f-0dc3db03ded0	1	2013-02-13
10702-016-03	EA - Each	10702-016	a8937c2c-d893-4b62-a57d-d235a1cc7c26	1	2013-02-13
10702-016-06	EA - Each	10702-016	573d2860-079a-4965-b5c9-f91ddde85e7d	1	2013-02-13
10702-016-10	EA - Each	10702-016	adae92bb-da61-47f1-8a0c-34f4404123ed	1	2013-02-13
10702-016-50	EA - Each	10702-016	185bfe82-a037-4950-b22b-74206f760515	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]	2
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-016	INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]	15	Current NDC, Legacy NDC, 6 package rows	20250322_dc80228c-acae-44dc-9762-19bd1669bf45.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
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 ndc (package): 10702-016-10 ndc (product): 10702-016 ndc11 (package): 10702001610

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
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	dc80228c-acae-44dc-9762-19bd1669bf45	15
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	dc80228c-acae-44dc-9762-19bd1669bf45	15
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	85014b51-1354-4d16-9995-3ee33a7155fa	13
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	85014b51-1354-4d16-9995-3ee33a7155fa	13
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	5a65b650-ea9b-4d0d-b62f-5971df1e62b4	10
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	5a65b650-ea9b-4d0d-b62f-5971df1e62b4	10
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	429e9731-cc5d-4089-bf4a-81ec22824c9e	2
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	6569dfd1-0164-4241-b508-ccd540d1e858	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	429e9731-cc5d-4089-bf4a-81ec22824c9e	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	6569dfd1-0164-4241-b508-ccd540d1e858	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-016-10	10702001610	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-10)	2009-03-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INDOMETHACIN	Bryant Ranch Prepack	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	104
Indomethacin	American Health Packaging	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	10
INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	2025-05-05	HUMAN PRESCRIPTION DRUG LABEL	13
INDOMETHACIN	KVK-Tech, Inc. \| Avanthi, Inc.	2025-03-18	HUMAN PRESCRIPTION DRUG LABEL	15
INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mg Rx Only	A-S Medication Solutions	2017-12-19	HUMAN PRESCRIPTION DRUG LABEL	11
INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mg Rx Only	Carilion Materials Management	2016-06-16	HUMAN PRESCRIPTION DRUG LABEL	2
INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP	Apotheca, Inc.	2010-04-16	HUMAN PRESCRIPTION DRUG LABEL	2