cefuroxime axetil

Generic: cefuroxime axetil

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0571
Product ID 80425-0571_48d96610-0a63-48c4-e063-6294a90a0388
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065496
Listing Expiration 2027-12-31
Marketing Start 2026-01-16

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250571
Hyphenated Format 80425-0571

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 ANDA065496 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (80425-0571-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0571-2)
source: ndc

Packages (2)

80425-0571-1 20 TABLET, FILM COATED in 1 BOTTLE (80425-0571-1) 80425-0571-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0571-2)

Ingredients (1)

cefuroxime axetil (500 mg/1)

Linked Drug Pages (1)

Cefuroxime axetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48d96610-0a63-48c4-e063-6294a90a0388", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309098"], "spl_set_id": ["48d96608-d3da-b512-e063-6294a90a07d5"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (80425-0571-1)", "package_ndc": "80425-0571-1", "marketing_start_date": "20260116"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0571-2)", "package_ndc": "80425-0571-2", "marketing_start_date": "20260116"}], "brand_name": "Cefuroxime axetil", "product_id": "80425-0571_48d96610-0a63-48c4-e063-6294a90a0388", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "80425-0571", "generic_name": "Cefuroxime axetil", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefuroxime axetil", "active_ingredients": [{"name": "CEFUROXIME AXETIL", "strength": "500 mg/1"}], "application_number": "ANDA065496", "marketing_category": "ANDA", "marketing_start_date": "20260116", "listing_expiration_date": "20271231"}