sulfasalazine

Generic: sulfasalazine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-5000
Product ID 59762-5000_7f481885-e195-4b1d-8fe3-27cc14ed59a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA007073
Listing Expiration 2026-12-31
Marketing Start 2003-07-01

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597625000
Hyphenated Format 59762-5000

Supplemental Identifiers

RxCUI
198232
UPC
0359762500014
UNII
3XC8GUZ6CB
NUI
N0000175781 M0000971

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulfasalazine (source: ndc)
Generic Name sulfasalazine (source: ndc)
Application Number NDA007073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59762-5000-5) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (59762-5000-6) / 300 TABLET in 1 BOTTLE
source: ndc

Packages (2)

59762-5000-5 1 BOTTLE in 1 CARTON (59762-5000-5) / 100 TABLET in 1 BOTTLE 59762-5000-6 1 BOTTLE in 1 CARTON (59762-5000-6) / 300 TABLET in 1 BOTTLE

Ingredients (1)

sulfasalazine (500 mg/1)

Linked Drug Pages (1)

Sulfasalazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f481885-e195-4b1d-8fe3-27cc14ed59a8", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0359762500014"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["48fbc535-a33a-45ee-85ff-9d1ec9b31d9c"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59762-5000-5)  / 100 TABLET in 1 BOTTLE", "package_ndc": "59762-5000-5", "marketing_start_date": "20200413"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (59762-5000-6)  / 300 TABLET in 1 BOTTLE", "package_ndc": "59762-5000-6", "marketing_start_date": "20200413"}], "brand_name": "Sulfasalazine", "product_id": "59762-5000_7f481885-e195-4b1d-8fe3-27cc14ed59a8", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "59762-5000", "generic_name": "Sulfasalazine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfasalazine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "NDA007073", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20030701", "listing_expiration_date": "20261231"}