sulfasalazine

Generic: sulfasalazine

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler sunrise pharmaceutical, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Sunrise Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11534-201
Product ID 11534-201_86d69175-60ab-4573-9c76-b995fc3a7802
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075339
Listing Expiration 2026-12-31
Marketing Start 2025-12-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11534201
Hyphenated Format 11534-201

Supplemental Identifiers

RxCUI
313142
UPC
0311534201017 0311534201079
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 ANDA075339 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01)
  • 300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)
source: ndc

Packages (2)

11534-201-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01) 11534-201-07 300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)

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": "86d69175-60ab-4573-9c76-b995fc3a7802", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0311534201017", "0311534201079"], "unii": ["3XC8GUZ6CB"], "rxcui": ["313142"], "spl_set_id": ["d596ac59-b643-4181-80ba-f2db1cc3459c"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Sunrise Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01)", "package_ndc": "11534-201-01", "marketing_start_date": "20251211"}, {"sample": false, "description": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)", "package_ndc": "11534-201-07", "marketing_start_date": "20251211"}], "brand_name": "Sulfasalazine", "product_id": "11534-201_86d69175-60ab-4573-9c76-b995fc3a7802", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "11534-201", "generic_name": "Sulfasalazine", "labeler_name": "Sunrise Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfasalazine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "ANDA075339", "marketing_category": "ANDA", "marketing_start_date": "20251211", "listing_expiration_date": "20261231"}