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
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Sunrise Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11534-200
Product ID 11534-200_97b74888-4b28-4f9a-b5b9-64d23bc7e808
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040349
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11534200
Hyphenated Format 11534-200

Supplemental Identifiers

RxCUI
198232
UPC
0311534200072 0311534200010 0311534200041
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 ANDA040349 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (11534-200-01)
  • 500 TABLET in 1 BOTTLE (11534-200-04)
  • 300 TABLET in 1 BOTTLE (11534-200-07)
source: ndc

Packages (3)

11534-200-01 100 TABLET in 1 BOTTLE (11534-200-01) 11534-200-04 500 TABLET in 1 BOTTLE (11534-200-04) 11534-200-07 300 TABLET in 1 BOTTLE (11534-200-07)

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": "97b74888-4b28-4f9a-b5b9-64d23bc7e808", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0311534200072", "0311534200010", "0311534200041"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["a54b31cc-205d-43d3-a850-acf4b41fbc37"], "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 in 1 BOTTLE (11534-200-01)", "package_ndc": "11534-200-01", "marketing_start_date": "20250715"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (11534-200-04)", "package_ndc": "11534-200-04", "marketing_start_date": "20250715"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (11534-200-07)", "package_ndc": "11534-200-07", "marketing_start_date": "20250715"}], "brand_name": "Sulfasalazine", "product_id": "11534-200_97b74888-4b28-4f9a-b5b9-64d23bc7e808", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "11534-200", "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": "ANDA040349", "marketing_category": "ANDA", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}