Indomethacin

Product NDC: 31722-565
11-digit product format: 317220565
Labeler code: 31722
Product ID: 31722-565_349e2ce2-f399-926c-e063-6294a90a9185
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA201807
Marketing category: ANDA
Marketing start: 2015-07-24
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
A201807-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201807-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`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	A201807-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	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
12f62bae-5fc0-4f8d-a8b4-446524bd53d1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
234b5275-84d6-d169-e08f-554a8aed3f0a	Product name	3	20250717
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
9aaf7cf4-60c3-b44f-e302-fd8b276c713b	Product name	2	20250107
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
97c70338-ee37-4c78-a047-53ee1cd9b53d	Product name	1	20150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-565-01	Indomethacin	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	7
31722-565-05	Indomethacin	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	7
31722-565-10	Indomethacin	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	7
31722-565-30	Indomethacin	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	7
31722-565-60	Indomethacin	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-565-01	EA - Each	31722-565	9bfd94a2-a3a8-47b5-85d0-030e2a11c002	1	2013-03-03
31722-565-60	EA - Each	31722-565	5383c6bf-40f9-4155-bc83-f95ee58831f8	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
POTASSIUM CATION	INACTIVE INGREDIENT	295O53K152	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [AVPAK]	3
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM CATION	INACTIVE INGREDIENT	295O53K152	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	2
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
POTASSIUM CATION	INACTIVE INGREDIENT	295O53K152	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
POTASSIUM CATION	INACTIVE INGREDIENT	295O53K152	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-565	INDOMETHACIN (INDOMETHACIN) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 5 package rows	20250509_12f62bae-5fc0-4f8d-a8b4-446524bd53d1.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Sportpharm LLC	12821a3a-b5f2-4415-84c9-0a30a4725f1e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	f2f59f63-fcda-2a80-e053-2995a90ab087	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	efa111d5-ade4-4944-97e4-3c37b8b14ea8	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	12f62bae-5fc0-4f8d-a8b4-446524bd53d1	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807 ndc (product): 31722-565
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	d54d6e12-e827-4248-819a-de76afa70371	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin ER	INDOMETHACIN	Advanced Rx Pharmacy of Tennessee, LLC	f4e8a719-ef9c-a2ef-e053-2995a90ad788	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	c6126527-5272-4477-8716-d05365a05225	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Proficient Rx LP	ac458b4b-95bb-4235-a447-e8c4ba720257	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807

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	c6126527-5272-4477-8716-d05365a05225	104
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	c6126527-5272-4477-8716-d05365a05225	104
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	d54d6e12-e827-4248-819a-de76afa70371	101
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	d54d6e12-e827-4248-819a-de76afa70371	101
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	23
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	23
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	efa111d5-ade4-4944-97e4-3c37b8b14ea8	8
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	efa111d5-ade4-4944-97e4-3c37b8b14ea8	8
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	12f62bae-5fc0-4f8d-a8b4-446524bd53d1	7
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	12f62bae-5fc0-4f8d-a8b4-446524bd53d1	7
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	f2f59f63-fcda-2a80-e053-2995a90ab087	4
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	f2f59f63-fcda-2a80-e053-2995a90ab087	4
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	12821a3a-b5f2-4415-84c9-0a30a4725f1e	3
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	12821a3a-b5f2-4415-84c9-0a30a4725f1e	3
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	ac458b4b-95bb-4235-a447-e8c4ba720257	2
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	1b8ee98e-3905-0c53-e054-00144ff8d46c	2
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	f4e8a719-ef9c-a2ef-e053-2995a90ad788	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	ac458b4b-95bb-4235-a447-e8c4ba720257	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	1b8ee98e-3905-0c53-e054-00144ff8d46c	2
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	f4e8a719-ef9c-a2ef-e053-2995a90ad788	2
310992	indomethacin 75 MG Extended Release Oral Capsule	PSN	ef9444e9-fc20-4139-ae74-ae9268e44a21	1
310992	indomethacin 75 MG Extended Release Oral Capsule	SCD	ef9444e9-fc20-4139-ae74-ae9268e44a21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-565-01	31722056501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-01)	2015-07-24	0000-00-00	No	No	Current
31722-565-05	31722056505	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-05)	2015-07-24	0000-00-00	No	No	Current
31722-565-10	31722056510	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-10)	2015-07-24	0000-00-00	No	No	Current
31722-565-30	31722056530	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-30)	2015-07-24	0000-00-00	No	No	Current
31722-565-60	31722056560	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-60)	2015-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin	REMEDYREPACK INC.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	24
Indomethacin	Sportpharm LLC	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	3
Indomethacin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Indomethacin Extended Release Capsules, USP	Bryant Ranch Prepack	2025-09-26	Human Prescription Drug Label	8
Indomethacin	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2025-05-08	HUMAN PRESCRIPTION DRUG LABEL	7
Indomethacin Extended Release Capsules, USP	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	101
Indomethacin ER Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Indomethacin Extended Release Capsules, USP	Bryant Ranch Prepack	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	104
Indomethacin Extended Release Capsules, USP	Proficient Rx LP	2023-07-28	HUMAN PRESCRIPTION DRUG LABEL	2
Indomethacin Extended Release Capsules, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2
Indomethacin Extended-release Capsules, USP Rx Only	AvPAK	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	6
Indomethacin Extended Release Capsules, USP	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	3
Indomethacin Extended Release Capsules, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	4
Indomethacin Extended Release Capsules, USP	A-S Medication Solutions	2018-03-14	Human Prescription Drug Label	3
Indomethacin Extended Release Capsules, USP Rx only	Blenheim Pharmacal, Inc.	2015-10-26	Human Prescription Drug Label	2
INDOMETHACIN	Direct RX	2015-07-02	HUMAN PRESCRIPTION DRUG LABEL	1