Sulfasalazine

Product NDC: 0603-5801
11-digit product format: 006035801
Labeler code: 0603
Product ID: 0603-5801_6706375c-9731-4dc7-b777-1459079a6419
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sulfasalazine
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA040349
Marketing category: ANDA
Marketing start: 2002-01-11
Marketing end: 2019-07-31
Substance: SULFASALAZINE
Active strength: 500 mg/1
Pharmacologic classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0603-5801		D	Discontinued by firm	2026-08-17
excluded package	package	0603-5801	0603-5801-04	D	Discontinued by firm	2026-08-17
excluded package	package	0603-5801	0603-5801-21	D	Discontinued by firm	2026-08-17
excluded package	package	0603-5801	0603-5801-28	D	Discontinued by firm	2026-08-17
excluded package	package	0603-5801	0603-5801-32	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 1 · 60 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	0603-5801-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-5801-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-5801-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-5801-04	`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	0603-5801-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-5801-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-5801-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-5801-04	`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	0603-5801-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-5801-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-5801-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-5801-04	`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	0603-5801-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-5801-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-5801-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-5801-04	`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	0603-5801-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-5801-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-5801-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-5801-04	`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	0603-5801-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-5801-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-5801-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-5801-04	`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	0603-5801-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-5801-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-5801-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-5801-04	`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	0603-5801-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-5801-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-5801-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-5801-04	`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	0603-5801-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-5801-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-5801-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-5801-04	`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	0603-5801-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-5801-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-5801-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-5801-04	`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	0603-5801-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-5801-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-5801-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-5801-04	`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	0603-5801-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-5801-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-5801-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-5801-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040349-001	SULFASALAZINE	SULFASALAZINE	500MG	TABLET / ORAL	AB		2002-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040349-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB	2002-01-11	`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	A040349-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040349-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040349-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040349-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040349-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040349-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040349-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040349-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040349-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040349-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040349-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040349-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040349-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040349-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040349-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040349-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040349-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040349-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040349-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040349-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040349-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040349-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040349-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040349-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040349-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040349-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040349-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040349-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040349-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040349-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040349-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040349-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040349-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040349-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040349-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040349-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040349-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040349-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040349-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040349-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
4c7fc883-c26b-34ca-837e-8c55868a2f87	Product name	1	20140508
56183ade-c831-0ad5-5cd8-c6b0b66bfab0	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-5801-04	EA - Each	0603-5801	fbd87adf-25f9-4357-9ca9-644e7cac4742	1	2012-07-24
0603-5801-21	EA - Each	0603-5801	6df961cf-a3fe-4076-b877-882d9531b591	1	2012-07-24
0603-5801-28	EA - Each	0603-5801	b78259a9-55f8-4e1e-942d-e285c16f2c05	1	2012-07-24
0603-5801-32	EA - Each	0603-5801	dcce3202-e966-4ec7-ba58-ac2e10b6f27e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFASALAZINE	ACTIVE INGREDIENT	3XC8GUZ6CB	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
SULFASALAZINE	ACTIVE INGREDIENT	3XC8GUZ6CB	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SULFASALAZINE	ACTIVE MOIETY	3XC8GUZ6CB	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
SULFASALAZINE	ACTIVE MOIETY	3XC8GUZ6CB	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

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
Sulfasalazine	SULFASALAZINE	Sunrise Pharmaceutical, Inc.	a54b31cc-205d-43d3-a850-acf4b41fbc37	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040349 application number: ANDA040349

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3XC8GUZ6CB	SULFASALAZINE	599-79-1	SULFASALAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	0ff320ac-60e1-4b75-e054-00144ff88e88	1
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	2fc8c918-157c-4898-9b26-80d9ae2fc143	1
198232	sulfasalazine 500 MG Oral Tablet	SCD	0ff320ac-60e1-4b75-e054-00144ff88e88	1
198232	sulfasalazine 500 MG Oral Tablet	SCD	2fc8c918-157c-4898-9b26-80d9ae2fc143	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SULFASALAZINE TABLETS, USP	Blenheim Pharmacal, Inc.	2015-02-25	HUMAN PRESCRIPTION DRUG LABEL	1
SULFASALAZINE TABLETS, USP	Aidarex Pharmaceuticals LLC	2014-02-01	HUMAN PRESCRIPTION DRUG LABEL	1