Sulfasalazine

Product NDC: 71610-706
11-digit product format: 716100706
Labeler code: 71610
Product ID: 71610-706_a5313f88-2d90-4f75-afb8-9dde2a069fa7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfasalazine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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

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
bf5137fe-60ed-4497-8521-eeb0a684fabf	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	Strength	SPL version
71610-706-70	Sulfasalazine	120 in 1 BOTTLE	TABLET	120		1
71610-706-80	Sulfasalazine	180 in 1 BOTTLE	TABLET	180		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-706-70	EA - Each	71610-706	df53eb3f-15f4-4dc0-ad93-6a12b346aa9a	1	2023-07-06
71610-706-80	EA - Each	71610-706	20949022-fe68-4912-bc20-649591ee14a0	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-706	SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, 2 package rows	20230517_bf5137fe-60ed-4497-8521-eeb0a684fabf.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
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 ndc (product): 71610-706

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	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	Sample	Exclude flag	Status
71610-706-70	71610070670	120 TABLET in 1 BOTTLE (71610-706-70)	120 tablet	2023-05-16	No	No	Current
71610-706-80	71610070680	180 TABLET in 1 BOTTLE (71610-706-80)	180 tablet	2023-05-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfasalazine Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	1