cefuroxime axetil

Generic: cefuroxime axetil

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1081
Product ID 67046-1081_2c3a51b0-6e4a-9ae0-e063-6394a90acc40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065308
Listing Expiration 2026-12-31
Marketing Start 2025-01-21

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461081
Hyphenated Format 67046-1081

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
  • 30 TABLET in 1 BLISTER PACK (67046-1081-3)
source: ndc

Packages (1)

67046-1081-3 30 TABLET in 1 BLISTER PACK (67046-1081-3)

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": "2c3a51b0-6e4a-9ae0-e063-6394a90acc40", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309098"], "spl_set_id": ["2c3a502f-8e72-c4d2-e063-6394a90a6fa5"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1081-3)", "package_ndc": "67046-1081-3", "marketing_start_date": "20250121"}], "brand_name": "Cefuroxime Axetil", "product_id": "67046-1081_2c3a51b0-6e4a-9ae0-e063-6394a90acc40", "dosage_form": "TABLET", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "67046-1081", "generic_name": "Cefuroxime Axetil", "labeler_name": "Coupler LLC", "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": "20250121", "listing_expiration_date": "20261231"}