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, DELAYED RELEASE
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0104
Product ID 59762-0104_d2a8dbd7-49db-4839-a5ee-0cbb39ae17ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA007073
Listing Expiration 2026-12-31
Marketing Start 2005-05-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597620104
Hyphenated Format 59762-0104

Supplemental Identifiers

RxCUI
313142
UPC
0359762010414
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 (59762-0104-5) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (59762-0104-6) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

59762-0104-5 1 BOTTLE in 1 CARTON (59762-0104-5) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE 59762-0104-6 1 BOTTLE in 1 CARTON (59762-0104-6) / 300 TABLET, DELAYED RELEASE 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": "d2a8dbd7-49db-4839-a5ee-0cbb39ae17ea", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0359762010414"], "unii": ["3XC8GUZ6CB"], "rxcui": ["313142"], "spl_set_id": ["257cee60-b68f-4c2b-b57d-8e4d73d17e09"], "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 (59762-0104-5)  / 100 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "59762-0104-5", "marketing_start_date": "20200323"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (59762-0104-6)  / 300 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "59762-0104-6", "marketing_start_date": "20200406"}], "brand_name": "Sulfasalazine", "product_id": "59762-0104_d2a8dbd7-49db-4839-a5ee-0cbb39ae17ea", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "59762-0104", "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": "20050505", "listing_expiration_date": "20261231"}