INDOCIN

Product NDC: 42211-101
11-digit product format: 422110101
Labeler code: 42211
Product ID: 42211-101_cbb49cf2-5c9b-4c5c-8d5b-7efbfdde1355
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: indomethacin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Iroko Pharmaceuticals, LLC
Application: NDA018332
Marketing category: NDA
Marketing start: 1985-10-10
Marketing end: 0000-00-00
Substance: INDOMETHACIN
Active strength: 25 mg/5mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42211-101		I	Inactivated by FDA	2026-08-03
excluded package	package	42211-101	42211-101-01	I	Inactivated by FDA	2026-08-03
excluded package	package	42211-101	42211-101-11	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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42211-101-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42211-101-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42211-101-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42211-101-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42211-101-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42211-101-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42211-101-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42211-101-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42211-101-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42211-101-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42211-101-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42211-101-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42211-101-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42211-101-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42211-101-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42211-101-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42211-101-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42211-101-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42211-101-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42211-101-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42211-101-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42211-101-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42211-101-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42211-101-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42211-101-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42211-101-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42211-101-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42211-101-11	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42211-101-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42211-101-11	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42211-101-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42211-101-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42211-101-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42211-101-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42211-101-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42211-101-11	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42211-101-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42211-101-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42211-101-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42211-101-11	`e2bbac7714bc…`	`27bdfed8d636…`

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
N018332-001	INDOCIN	INDOMETHACIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018332-001	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	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1985-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018332-001	INDOCIN	25MG/5ML	SUSPENSION / ORAL		RLD, RS	1985-10-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018332-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018332-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018332-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018332-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018332-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018332-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018332-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018332-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018332-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018332-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018332-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018332-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018332-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018332-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018332-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018332-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018332-001	AB	1	`a50c72e98297…`

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42211-101-01	2020-01-31	C162847	48780-1	9d75b9d0-aa26-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use INDOCIN ® ORAL SUSPENSION safely and effectively. See full prescribing information for INDOCIN . INDOCIN ( indomethacin ) Oral Suspension , for oral use Initial U.S. Approval: 1965
42211-101-11	2020-01-31	C162847	48780-1	9d75b9d0-aa26-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use INDOCIN ® ORAL SUSPENSION safely and effectively. See full prescribing information for INDOCIN . INDOCIN ( indomethacin ) Oral Suspension , for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42211-101-01	INDOCIN	1 in 1 CARTON	SUSPENSION	1	11
42211-101-01	INDOCIN	50 mL in 1 BOTTLE	SUSPENSION	50	11
42211-101-11	INDOCIN	237 mL in 1 BOTTLE	SUSPENSION	237	11
42211-101-11	INDOCIN	1 in 1 CARTON	SUSPENSION	1	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42211-101-11	ML - Milliliter	42211-101	99d472b3-b858-4ecd-bae6-2dd78de9023d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
SORBITOL	INACTIVE INGREDIENT	506T60A25R	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
TRAGACANTH	INACTIVE INGREDIENT	2944357O2O	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42211-101	INDOCIN (INDOMETHACIN) SUSPENSION [IROKO PHARMACEUTICALS, LLC]	11	Legacy NDC, 4 package rows	20180521_06de3c9d-63bf-47c1-f78c-4fbdd482928a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indocin	INDOMETHACIN	Zyla Life Sciences US LLC	73878376-1d24-423b-9f37-3666e83c95da	2024-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018332 application number: NDA018332

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
206971	Indocin 25 MG in 5 mL Oral Suspension	PSN	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11
310991	indomethacin 25 MG in 5 mL Oral Suspension	PSN	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11
206971	indomethacin 5 MG/ML Oral Suspension [Indocin]	SBD	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11
310991	indomethacin 5 MG/ML Oral Suspension	SCD	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11
206971	Indocin 25 MG per 5 ML Oral Suspension	SY	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11
206971	Indocin 5 MG/ML Oral Suspension	SY	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11
310991	indomethacin 25 MG per 5 ML Oral Suspension	SY	06de3c9d-63bf-47c1-f78c-4fbdd482928a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42211-101-01	42211010101	1 in 1 CARTON		Historical
42211-101-11	42211010111	237 mL in 1 BOTTLE	237 ml	Historical