sulfasalazine

Generic: sulfasalazine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-706
Product ID 71610-706_a5313f88-2d90-4f75-afb8-9dde2a069fa7
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 71610706
Hyphenated Format 71610-706

Supplemental Identifiers

RxCUI
198232
UNII
3XC8GUZ6CB
NUI
N0000175781 M0000971

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
  • 120 TABLET in 1 BOTTLE (71610-706-70)
  • 180 TABLET in 1 BOTTLE (71610-706-80)
source: ndc

Packages (2)

71610-706-70 120 TABLET in 1 BOTTLE (71610-706-70) 71610-706-80 180 TABLET in 1 BOTTLE (71610-706-80)

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": "a5313f88-2d90-4f75-afb8-9dde2a069fa7", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["bf5137fe-60ed-4497-8521-eeb0a684fabf"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-706-70)", "package_ndc": "71610-706-70", "marketing_start_date": "20230516"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-706-80)", "package_ndc": "71610-706-80", "marketing_start_date": "20230516"}], "brand_name": "Sulfasalazine", "product_id": "71610-706_a5313f88-2d90-4f75-afb8-9dde2a069fa7", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "71610-706", "generic_name": "Sulfasalazine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}