sulfasalazine

Generic: sulfasalazine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3234
Product ID 0093-3234_6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085828
Listing Expiration 2026-12-31
Marketing Start 2022-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00933234
Hyphenated Format 0093-3234

Supplemental Identifiers

RxCUI
198232
UPC
0300933234016
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 ANDA085828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0093-3234-10)
source: ndc

Packages (3)

0093-3234-01 100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01) 0093-3234-05 500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05) 0093-3234-10 1000 TABLET in 1 BOTTLE, PLASTIC (0093-3234-10)

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": "6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0300933234016"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["3c59593b-e1a5-47cb-a82b-3e5e49205344"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01)", "package_ndc": "0093-3234-01", "marketing_start_date": "20221215"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05)", "package_ndc": "0093-3234-05", "marketing_start_date": "20230227"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0093-3234-10)", "package_ndc": "0093-3234-10", "marketing_start_date": "20221215"}], "brand_name": "Sulfasalazine", "product_id": "0093-3234_6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0093-3234", "generic_name": "Sulfasalazine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfasalazine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "ANDA085828", "marketing_category": "ANDA", "marketing_start_date": "20221215", "listing_expiration_date": "20261231"}