Sulindac

Product NDC: 63629-3208
11-digit product format: 636293208
Labeler code: 63629
Product ID: 63629-3208_d150c3f3-c267-4d48-9502-4700670c954b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulindac
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
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],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3208		D	Discontinued by firm	2026-08-17
excluded package	package	63629-3208	63629-3208-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3208	63629-3208-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3208	63629-3208-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3208	63629-3208-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3208	63629-3208-5	D	Discontinued by firm	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 2 · 78 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	63629-3208-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3208-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3208-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3208-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3208-1	`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	63629-3208-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3208-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3208-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3208-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3208-1	`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	63629-3208-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3208-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3208-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3208-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3208-1	`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	63629-3208-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3208-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3208-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3208-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3208-1	`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	63629-3208-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3208-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3208-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3208-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3208-1	`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	63629-3208-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3208-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3208-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3208-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3208-1	`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	63629-3208-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3208-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3208-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3208-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3208-1	`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	63629-3208-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3208-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3208-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3208-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3208-1	`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	63629-3208-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3208-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3208-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3208-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3208-1	`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	63629-3208-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3208-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3208-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3208-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3208-1	`ad56d346431e…`	`cc804d4bbf1e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3208-1	2020-10-16	Sulindac Tablets, USP Rx only
63629-3208-2	2020-10-16	Sulindac Tablets, USP Rx only
63629-3208-3	2020-10-16	Sulindac Tablets, USP Rx only
63629-3208-4	2020-10-16	Sulindac Tablets, USP Rx only
63629-3208-5	2020-10-16	Sulindac Tablets, USP Rx only
63629-3208-1	2020-01-31	Sulindac Tablets, USP Rx only
63629-3208-2	2020-01-31	Sulindac Tablets, USP Rx only
63629-3208-3	2020-01-31	Sulindac Tablets, USP Rx only
63629-3208-4	2020-01-31	Sulindac Tablets, USP Rx only
63629-3208-5	2020-01-31	Sulindac Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3208-1	EA - Each	63629-3208	751099cb-a1f9-45c7-84d4-0e33cdee3346	1	2013-02-13
63629-3208-2	EA - Each	63629-3208	063fe264-23af-48b8-9ae7-a95f4506c0f3	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [BRYANT RANCH PREPACK]	1001
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [BRYANT RANCH PREPACK]	1001
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [BRYANT RANCH PREPACK]	1001

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3208-1	63629320801	30 TABLET in 1 BOTTLE (63629-3208-1)	30 tablet	2006-12-27	0000-00-00	No	No	Current
63629-3208-2	63629320802	60 TABLET in 1 BOTTLE (63629-3208-2)	60 tablet	2006-12-27	0000-00-00	No	No	Current
63629-3208-3	63629320803	20 TABLET in 1 BOTTLE (63629-3208-3)	20 tablet	2006-12-27	0000-00-00	No	No	Current
63629-3208-4	63629320804	14 TABLET in 1 BOTTLE (63629-3208-4)	14 tablet	2006-12-27	0000-00-00	No	No	Current
63629-3208-5	63629320805	90 TABLET in 1 BOTTLE (63629-3208-5)	90 tablet	2006-12-27	0000-00-00	No	No	Current