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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	2026-07-31
excluded package	package	0603-5801	0603-5801-04	D	Discontinued by firm	2026-07-31
excluded package	package	0603-5801	0603-5801-21	D	Discontinued by firm	2026-07-31
excluded package	package	0603-5801	0603-5801-28	D	Discontinued by firm	2026-07-31
excluded package	package	0603-5801	0603-5801-32	D	Discontinued by firm	2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

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
2026-08-01 22:54:32	2026-06	A040349-001	SULFASALAZINE	500MG	TABLET / ORAL	AB		2002-01-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040349-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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