cefuroxime axetil

Generic: cefuroxime axetil

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8905
Product ID 68788-8905_bc9200d2-4a6d-4847-ba85-8e9d378390de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065308
Listing Expiration 2026-12-31
Marketing Start 2025-07-31

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888905
Hyphenated Format 68788-8905

Supplemental Identifiers

RxCUI
309098
UNII
Z49QDT0J8Z

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 cefuroxime axetil (source: ndc)
Generic Name cefuroxime axetil (source: ndc)
Application Number ANDA065308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8905-2)
source: ndc

Packages (1)

Ingredients (1)

cefuroxime axetil (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "bc9200d2-4a6d-4847-ba85-8e9d378390de", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309098"], "spl_set_id": ["bc9200d2-4a6d-4847-ba85-8e9d378390de"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8905-2)", "package_ndc": "68788-8905-2", "marketing_start_date": "20250731"}], "brand_name": "Cefuroxime Axetil", "product_id": "68788-8905_bc9200d2-4a6d-4847-ba85-8e9d378390de", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "68788-8905", "generic_name": "Cefuroxime Axetil", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefuroxime Axetil", "active_ingredients": [{"name": "CEFUROXIME AXETIL", "strength": "500 mg/1"}], "application_number": "ANDA065308", "marketing_category": "ANDA", "marketing_start_date": "20250731", "listing_expiration_date": "20261231"}