INDOMETHACIN

Product NDC: 61919-130
Requested package NDC: 61919-130-60
11-digit product format: 619190130
Labeler code: 61919
Product ID: 61919-130_4c48328a-3597-50f2-e063-6294a90af8ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: INDOMETHACIN
Dosage form: CAPSULE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091240
Marketing category: ANDA
Marketing start: 2014-01-01
Substance: INDOMETHACIN
Active strength: 50 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-130	61919-130-60	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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.

Product history page 1 of 3 · 82 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	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091240-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091240-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091240-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091240-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091240-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091240-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDOMETHACIN	50 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
197818	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
7e7175d7-5e43-4151-9702-88ac2cd44ef6	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-130-15	2025-01-30	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-30	2025-01-30	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-60	2025-01-30	2cef2736-a71a-d83d-e063-dadaa90ab31f	INDOMETHACIN
61919-130-90	2025-01-30	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-15	2020-12-14	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-30	2020-12-14	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-90	2020-12-14	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-15	2020-01-31	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-30	2020-01-31	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN
61919-130-90	2020-01-31	9d75b9d0-4099-f424-e053-dadaa90a57ce	INDOMETHACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-130-15	INDOMETHACIN	15 in 1 BOTTLE	CAPSULE	15	7
61919-130-21	INDOMETHACIN	21 in 1 BOTTLE	CAPSULE	21	7
61919-130-30	INDOMETHACIN	30 in 1 BOTTLE	CAPSULE	30	7
61919-130-90	INDOMETHACIN	90 in 1 BOTTLE	CAPSULE	90	7
61919-130-60	INDOMETHACIN	60 in 1 BOTTLE	CAPSULE	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-130-15	EA - Each	61919-130	123f7c9e-cd67-442b-816a-cf6d807dcb3f	1	2016-07-19
61919-130-60	EA - Each	61919-130	8dd10479-8fca-49b9-9dd6-f266e6f0535b	1	2019-09-05
61919-130-90	EA - Each	61919-130	d3a69dda-6163-4dc9-955c-f2e3e4fc4bb6	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [DIRECT RX]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [DIRECT RX]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [DIRECT RX]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [DIRECT RX]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [DIRECT RX]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [DIRECT RX]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [DIRECT RX]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [DIRECT RX]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-130	INDOMETHACIN CAPSULE [DIRECT RX]	6	Current NDC, Legacy NDC, 4 package rows	20230412_7e7175d7-5e43-4151-9702-88ac2cd44ef6.zip
61919-130	INDOMETHACIN CAPSULE [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20200121_9131abdc-dd9c-22f1-e053-2a95a90ab011.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 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 ndc (product): 61919-130
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

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
197818	indomethacin 50 MG Oral Capsule	PSN	7e7175d7-5e43-4151-9702-88ac2cd44ef6	7
197818	indomethacin 50 MG Oral Capsule	SCD	7e7175d7-5e43-4151-9702-88ac2cd44ef6	7
197818	indomethacin 50 MG Oral Capsule	PSN	9131abdc-dd9c-22f1-e053-2a95a90ab011	2
197818	indomethacin 50 MG Oral Capsule	SCD	9131abdc-dd9c-22f1-e053-2a95a90ab011	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-130-60	61919013060	60 CAPSULE in 1 BOTTLE (61919-130-60)	60 capsule	2019-08-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INDOMETHACIN	DIRECT RX	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
INDOMETHACIN	Direct_Rx	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2