sulfasalazine

Generic: sulfasalazine

Labeler: chartwell rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler chartwell rx, llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-960
Product ID 62135-960_ef9f56ad-c921-6fe7-e053-2a95a90a85af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080197
Listing Expiration 2026-12-31
Marketing Start 1973-11-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135960
Hyphenated Format 62135-960

Supplemental Identifiers

RxCUI
198232
UPC
0362135960018 0362135960056 0362135960315 0362135960100
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 ANDA080197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62135-960-01)
  • 500 TABLET in 1 BOTTLE (62135-960-05)
  • 1000 TABLET in 1 BOTTLE (62135-960-10)
  • 300 TABLET in 1 BOTTLE (62135-960-31)
source: ndc

Packages (4)

62135-960-01 100 TABLET in 1 BOTTLE (62135-960-01) 62135-960-05 500 TABLET in 1 BOTTLE (62135-960-05) 62135-960-10 1000 TABLET in 1 BOTTLE (62135-960-10) 62135-960-31 300 TABLET in 1 BOTTLE (62135-960-31)

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": "ef9f56ad-c921-6fe7-e053-2a95a90a85af", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0362135960018", "0362135960056", "0362135960315", "0362135960100"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["029716bd-ee1a-484c-bf1f-ec8d02d5281b"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62135-960-01)", "package_ndc": "62135-960-01", "marketing_start_date": "20210507"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62135-960-05)", "package_ndc": "62135-960-05", "marketing_start_date": "20210507"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62135-960-10)", "package_ndc": "62135-960-10", "marketing_start_date": "20210507"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (62135-960-31)", "package_ndc": "62135-960-31", "marketing_start_date": "20210507"}], "brand_name": "Sulfasalazine", "product_id": "62135-960_ef9f56ad-c921-6fe7-e053-2a95a90a85af", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "62135-960", "generic_name": "Sulfasalazine", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfasalazine", "active_ingredients": [{"name": "SULFASALAZINE", "strength": "500 mg/1"}], "application_number": "ANDA080197", "marketing_category": "ANDA", "marketing_start_date": "19731112", "listing_expiration_date": "20261231"}