Sulfasalazine

Product NDC: 59762-5000
Requested package NDC: 59762-5000-1
11-digit product format: 597625000
Labeler code: 59762
Product ID: 59762-5000_7f481885-e195-4b1d-8fe3-27cc14ed59a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfasalazine
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA007073
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2003-07-01
Substance: SULFASALAZINE
Active strength: 500 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59762-5000	59762-5000-1	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N007073-001	AZULFIDINE	SULFASALAZINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N007073-002	AZULFIDINE EN-TABS	SULFASALAZINE	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N007073-001	AB
N007073-002	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 3 · 84 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	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007073-001	AZULFIDINE	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N007073-002	AZULFIDINE EN-TABS	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1983-04-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N007073-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007073-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N007073-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007073-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007073-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007073-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007073-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007073-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007073-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007073-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007073-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007073-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007073-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007073-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007073-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007073-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007073-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007073-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007073-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007073-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007073-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N007073-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007073-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007073-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007073-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007073-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007073-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007073-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007073-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N007073-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007073-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007073-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007073-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N007073-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007073-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N007073-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007073-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N007073-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007073-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N007073-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sulfasalazine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFASALAZINE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3XC8GUZ6CB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198232	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48fbc535-a33a-45ee-85ff-9d1ec9b31d9c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4c7fc883-c26b-34ca-837e-8c55868a2f87	Product name	1	20140508
56183ade-c831-0ad5-5cd8-c6b0b66bfab0	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59762-5000-1	Sulfasalazine	100 in 1 BOTTLE	TABLET	100	26
59762-5000-2	Sulfasalazine	300 in 1 BOTTLE	TABLET	300	26
59762-5000-5	Sulfasalazine	1 in 1 CARTON	TABLET	1	26
59762-5000-5	Sulfasalazine	100 in 1 BOTTLE	TABLET	100	26
59762-5000-6	Sulfasalazine	1 in 1 CARTON	TABLET	1	26
59762-5000-6	Sulfasalazine	300 in 1 BOTTLE	TABLET	300	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-5000-1	EA - Each	59762-5000	ad13d369-308e-4276-8f03-c2733f0137fe	1	2012-07-24
59762-5000-2	EA - Each	59762-5000	a5a081d5-c0a9-4d71-88c6-328344070a6f	1	2012-07-24
59762-5000-5	EA - Each	59762-5000	ad74d621-2fbb-444f-ae0b-9a01f2a5719b	1	2020-05-08
59762-5000-6	EA - Each	59762-5000	8135fb29-9ebc-4492-8cb1-d58c21624052	1	2020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFASALAZINE	ACTIVE INGREDIENT	3XC8GUZ6CB	SULFASALAZINE TABLET [GREENSTONE LLC]	10
SULFASALAZINE	ACTIVE MOIETY	3XC8GUZ6CB	SULFASALAZINE TABLET [GREENSTONE LLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFASALAZINE TABLET [GREENSTONE LLC]	10
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SULFASALAZINE TABLET [GREENSTONE LLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SULFASALAZINE TABLET [GREENSTONE LLC]	10
SULFASALAZINE	ACTIVE INGREDIENT	3XC8GUZ6CB	SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SULFASALAZINE	ACTIVE INGREDIENT	3XC8GUZ6CB	SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SULFASALAZINE	ACTIVE MOIETY	3XC8GUZ6CB	SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SULFASALAZINE	ACTIVE MOIETY	3XC8GUZ6CB	SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-5000	SULFASALAZINE TABLET [GREENSTONE LLC]	25	Current NDC, Legacy NDC, 6 package rows	20250223_48fbc535-a33a-45ee-85ff-9d1ec9b31d9c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azulfidine	SULFASALAZINE	Pfizer Laboratories Div Pfizer Inc	ddbe69f3-bd55-45f3-a64f-f60226c744c4	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073
Azulfidine EN-tabs	SULFASALAZINE	Pfizer Laboratories Div Pfizer Inc	b9ef541a-93c8-4428-ba45-398aa0b327d1	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073
Sulfasalazine	SULFASALAZINE	REMEDYREPACK INC.	88441a9f-b4f9-455d-a355-46fb30699a7b	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073
Sulfasalazine	SULFASALAZINE	Mylan Pharmaceuticals Inc.	257cee60-b68f-4c2b-b57d-8e4d73d17e09	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073
Sulfasalazine	SULFASALAZINE	Mylan Pharmaceuticals Inc.	48fbc535-a33a-45ee-85ff-9d1ec9b31d9c	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073 ndc (package): 59762-5000-1 ndc (product): 59762-5000 ndc11 (package): 59762500001
Sulfasalazine	SULFASALAZINE	A-S Medication Solutions	76b532a3-e7ca-4929-8c51-c0f66e0806a8	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073
Sulfasalazine	SULFASALAZINE	A-S Medication Solutions	32fd1726-ed81-4441-9594-3aecf2db1dbf	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073
Sulfasalazine	SULFASALAZINE	Aphena Pharma Solutions - Tennessee, LLC	bf5137fe-60ed-4497-8521-eeb0a684fabf	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007073 application number: NDA007073

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	48fbc535-a33a-45ee-85ff-9d1ec9b31d9c	26
198232	sulfasalazine 500 MG Oral Tablet	SCD	48fbc535-a33a-45ee-85ff-9d1ec9b31d9c	26
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	32fd1726-ed81-4441-9594-3aecf2db1dbf	20
198232	sulfasalazine 500 MG Oral Tablet	SCD	32fd1726-ed81-4441-9594-3aecf2db1dbf	20
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	88441a9f-b4f9-455d-a355-46fb30699a7b	15
198232	sulfasalazine 500 MG Oral Tablet	SCD	88441a9f-b4f9-455d-a355-46fb30699a7b	15
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	76b532a3-e7ca-4929-8c51-c0f66e0806a8	3
198232	sulfasalazine 500 MG Oral Tablet	SCD	76b532a3-e7ca-4929-8c51-c0f66e0806a8	3
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	a5a23c68-f5bd-42dd-b72c-0641659bae46	2
198232	sulfasalazine 500 MG Oral Tablet	SCD	a5a23c68-f5bd-42dd-b72c-0641659bae46	2
198232	sulfaSALAzine 500 MG Oral Tablet	PSN	bf5137fe-60ed-4497-8521-eeb0a684fabf	1
198232	sulfasalazine 500 MG Oral Tablet	SCD	bf5137fe-60ed-4497-8521-eeb0a684fabf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-5000-1	59762500001	100 TABLET in 1 BOTTLE (59762-5000-1)	100 tablet	2003-07-01	2024-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfasalazine Tablets, USP	REMEDYREPACK INC.	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	15
Sulfasalazine Tablets, USP	Mylan Pharmaceuticals Inc.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	26
Sulfasalazine Tablets, USP	A-S Medication Solutions	2025-04-08	HUMAN PRESCRIPTION DRUG LABEL	20
Sulfasalazine Tablets, USP	A-S Medication Solutions	2025-04-08	HUMAN PRESCRIPTION DRUG LABEL	3
Sulfasalazine Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	1
Sulfasalazine Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-12-18	HUMAN PRESCRIPTION DRUG LABEL	2