sulfasalazine

Generic: sulfasalazine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-261
Product ID 16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219046
Listing Expiration 2026-12-31
Marketing Start 2025-11-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571261
Hyphenated Format 16571-261

Supplemental Identifiers

RxCUI
198232
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 ANDA219046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CONTAINER (16571-261-01)
  • 300 TABLET in 1 CONTAINER (16571-261-30)
source: ndc

Packages (2)

16571-261-01 100 TABLET in 1 CONTAINER (16571-261-01) 16571-261-30 300 TABLET in 1 CONTAINER (16571-261-30)

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": "4b43540c-2b08-44cb-81b8-4308dea2c141", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["3254432e-87a4-4af0-afd1-d9e6f1b0efd4"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CONTAINER (16571-261-01)", "package_ndc": "16571-261-01", "marketing_start_date": "20251104"}, {"sample": false, "description": "300 TABLET in 1 CONTAINER (16571-261-30)", "package_ndc": "16571-261-30", "marketing_start_date": "20251104"}], "brand_name": "Sulfasalazine", "product_id": "16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "16571-261", "generic_name": "Sulfasalazine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfasalazine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "ANDA219046", "marketing_category": "ANDA", "marketing_start_date": "20251104", "listing_expiration_date": "20261231"}