Sulindac

Product NDC: 54738-903
11-digit product format: 547380903
Labeler code: 54738
Product ID: 54738-903_034a7f71-4589-441c-b585-d57be8942b80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulindac
Dosage form: TABLET
Route: ORAL
Labeler: Richmond Pharmaceuticals
Application: ANDA072051
Marketing category: ANDA
Marketing start: 2009-09-04
Marketing end: 0000-00-00
Substance: SULINDAC
Active strength: 200 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	54738-903		I	Inactivated by FDA	2026-10-16
excluded package	package	54738-903	54738-903-01	I	Inactivated by FDA	2026-10-16
excluded package	package	54738-903	54738-903-02	I	Inactivated by FDA	2026-10-16

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 · 66 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	54738-903-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54738-903-01	`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	54738-903-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54738-903-01	`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	54738-903-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54738-903-01	`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	54738-903-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54738-903-01	`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	54738-903-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54738-903-01	`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	54738-903-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54738-903-01	`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	54738-903-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54738-903-01	`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	54738-903-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54738-903-01	`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	54738-903-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54738-903-01	`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	54738-903-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54738-903-01	`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	54738-903-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54738-903-01	`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	54738-903-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54738-903-01	`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	54738-903-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54738-903-01	`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	54738-903-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54738-903-01	`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	54738-903-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54738-903-01	`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	54738-903-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54738-903-01	`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	54738-903-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54738-903-01	`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	54738-903-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54738-903-01	`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	54738-903-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54738-903-01	`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	54738-903-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54738-903-01	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A072051-001	SULINDAC	SULINDAC	200MG	TABLET / ORAL	AB		1991-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072051-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072051-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-04-17	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A072051-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072051-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072051-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072051-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c7c8244c-3606-b814-8453-06ab13fc5907	Product name	2	20201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54738-903-01	2019-10-29	C162847	48780-1	960f7f55-d19c-8e05-e053-dbdaa90a074a	SULINDAC TABLETS USP
54738-903-02	2019-10-29	C162847	48780-1	960f7f55-d19c-8e05-e053-dbdaa90a074a	SULINDAC TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54738-903-01	Sulindac	100 in 1 BOTTLE, PLASTIC	TABLET	100		2
54738-903-02	Sulindac	500 in 1 BOTTLE, PLASTIC	TABLET	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54738-903-01	EA - Each	54738-903	6497b6c9-7327-4f63-9167-bf501c69bf94	1	2012-07-24
54738-903-02	EA - Each	54738-903	45ecc3cd-eabb-4c83-babf-a8891c71eb20	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Sulindac	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [RICHMOND PHARMACEUTICALS]	2
Sulindac	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [RICHMOND PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54738-903	SULINDAC TABLET [RICHMOND PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20110603_89b01ca5-cfa5-4f5d-be6b-927d58cce0f2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SULINDAC	SULINDAC	A-S Medication Solutions	f4985b1b-7e2c-4911-897a-94c337794bab	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072051 application number: ANDA072051
SULINDAC	SULINDAC	PD-Rx Pharmaceuticals, Inc.	1fffe88d-50c8-45cf-ac7c-a62b665c89a8	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072051 application number: ANDA072051
SULINDAC	SULINDAC	Sun Pharmaceutical Industries, Inc.	a47e4259-d44b-4b7b-b517-841cb6840982	2024-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072051 application number: ANDA072051

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
184SNS8VUH	SULINDAC	38194-50-2	SULINDAC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198238	sulindac 150 MG Oral Tablet	PSN	89b01ca5-cfa5-4f5d-be6b-927d58cce0f2	2
198239	sulindac 200 MG Oral Tablet	PSN	89b01ca5-cfa5-4f5d-be6b-927d58cce0f2	2
198238	sulindac 150 MG Oral Tablet	SCD	89b01ca5-cfa5-4f5d-be6b-927d58cce0f2	2
198239	sulindac 200 MG Oral Tablet	SCD	89b01ca5-cfa5-4f5d-be6b-927d58cce0f2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54738-903-01	54738090301	100 in 1 BOTTLE, PLASTIC	Historical
54738-903-02	54738090302	500 in 1 BOTTLE, PLASTIC	Historical