sulfasalazine

Generic: sulfasalazine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfasalazine
Generic Name sulfasalazine
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfasalazine 500 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9715
Product ID 63629-9715_00104d3b-3b62-49fb-8a04-26ec7c24efcc
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 636299715
Hyphenated Format 63629-9715

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 ANDA085828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1)
source: ndc

Packages (1)

63629-9715-1 90 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1)

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": "00104d3b-3b62-49fb-8a04-26ec7c24efcc", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["3XC8GUZ6CB"], "rxcui": ["198232"], "spl_set_id": ["618c5324-d0a6-4d00-9b12-0de88a71c180"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1)", "package_ndc": "63629-9715-1", "marketing_start_date": "20230622"}], "brand_name": "Sulfasalazine", "product_id": "63629-9715_00104d3b-3b62-49fb-8a04-26ec7c24efcc", "dosage_form": "TABLET", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "63629-9715", "generic_name": "Sulfasalazine", "labeler_name": "Bryant Ranch Prepack", "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"}