Sulindac

Product NDC: 52959-195
11-digit product format: 529590195
Labeler code: 52959
Product ID: 52959-195_91275e67-c112-480e-b4c9-1de9f51ac081
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulindac
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA071795
Marketing category: ANDA
Marketing start: 1990-04-03
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: 2018-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-195		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-14	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-15	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-18	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-28	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-195	52959-195-60	I	Inactivated by FDA	2026-08-17

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 3 · 176 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	52959-195-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-195-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-195-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-195-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-195-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-195-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-195-28	`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	52959-195-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-195-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-195-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-195-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-195-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-195-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-195-28	`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	52959-195-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-195-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-195-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-195-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-195-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-195-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-195-28	`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	52959-195-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-195-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-195-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-195-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-195-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-195-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-195-28	`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	52959-195-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-195-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-195-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-195-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-195-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-195-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-195-28	`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	52959-195-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-195-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-195-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-195-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-195-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-195-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-195-28	`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	52959-195-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-195-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-195-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-195-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-195-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-195-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-195-28	`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	52959-195-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-195-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-195-18	`ed331223b511…`	`672a5bd82f5f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A071795-001	SULINDAC	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071795-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A071795-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071795-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071795-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071795-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071795-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071795-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071795-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071795-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071795-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071795-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071795-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071795-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071795-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071795-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071795-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071795-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071795-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071795-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071795-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071795-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071795-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071795-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071795-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071795-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071795-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071795-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071795-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071795-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071795-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071795-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071795-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071795-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071795-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071795-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071795-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071795-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071795-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071795-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071795-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071795-001	AB	1	`e64feba35796…`

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, Related label table
NDC	Related label
52959-195-14	Sulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-15	Sulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-18	Sulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-20	Sulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-28	Sulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-30	Sulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-60	Sulindac Tablets USP Revised: June 2009 Rx only 190770

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-195-14	Sulindac	14 in 1 BOTTLE, PLASTIC	TABLET	14	1
52959-195-15	Sulindac	15 in 1 BOTTLE, PLASTIC	TABLET	15	1
52959-195-18	Sulindac	18 in 1 BOTTLE, PLASTIC	TABLET	18	1
52959-195-20	Sulindac	20 in 1 BOTTLE, PLASTIC	TABLET	20	1
52959-195-28	Sulindac	28 in 1 BOTTLE, PLASTIC	TABLET	28	1
52959-195-30	Sulindac	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
52959-195-60	Sulindac	60 in 1 BOTTLE, PLASTIC	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-195-14	EA - Each	52959-195	c5d923c7-1e58-4669-89ee-b614435167f2	1	2012-07-24
52959-195-15	EA - Each	52959-195	9b4c50ad-5c6d-41e6-8828-4f5cec740866	1	2012-07-24
52959-195-18	EA - Each	52959-195	5b26f83e-9b1b-45bb-9d73-561d2ce85f4f	1	2015-10-02
52959-195-20	EA - Each	52959-195	c1e89864-25a9-4258-b55f-377146996576	1	2012-07-24
52959-195-28	EA - Each	52959-195	ce4f1e1f-56eb-41d2-b8bc-7cbff69d12ae	1	2012-07-24
52959-195-30	EA - Each	52959-195	4810331c-7c07-46b5-8bc2-b58b2df2897d	1	2012-07-24
52959-195-60	EA - Each	52959-195	7009e183-6751-48c0-ae71-72c831d4cd79	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-195	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 7 package rows	20111201_145a1b4a-16ef-4f29-b47e-f52c47514c9a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulindac	SULINDAC	PD-Rx Pharmaceuticals, Inc.	68d4eeed-2501-494b-b979-502720de86c0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071795 application number: ANDA071795
Sulindac	SULINDAC	Actavis Pharma, Inc.	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071795 application number: ANDA071795

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
198239	sulindac 200 MG Oral Tablet	PSN	145a1b4a-16ef-4f29-b47e-f52c47514c9a	1
198239	sulindac 200 MG Oral Tablet	SCD	145a1b4a-16ef-4f29-b47e-f52c47514c9a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-195-14	52959019514	14 in 1 BOTTLE, PLASTIC	Historical
52959-195-15	52959019515	15 in 1 BOTTLE, PLASTIC	Historical
52959-195-18	52959019518	18 in 1 BOTTLE, PLASTIC	Historical
52959-195-20	52959019520	20 in 1 BOTTLE, PLASTIC	Historical
52959-195-28	52959019528	28 in 1 BOTTLE, PLASTIC	Historical
52959-195-30	52959019530	30 in 1 BOTTLE, PLASTIC	Historical
52959-195-60	52959019560	60 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulindac Tablets USP Revised: June 2009 Rx only 190770	H.J. Harkins Company, Inc. \| Watson Laboratories, Inc. \| Watson Laboratories, Inc. - Florida \| Watson Pharma Private Limited	2011-10-28	HUMAN PRESCRIPTION DRUG LABEL	1