cefuroxime axetil

Generic: cefuroxime axetil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-700
Product ID 65862-700_5716a24a-653f-488a-bb44-85abffcbf92c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065308
Listing Expiration 2026-12-31
Marketing Start 2006-03-29

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862700
Hyphenated Format 65862-700

Supplemental Identifiers

RxCUI
309095 309097 309098
UNII
Z49QDT0J8Z

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 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 in 1 BOTTLE (65862-700-20)
  • 60 TABLET in 1 BOTTLE (65862-700-60)
source: ndc

Packages (2)

65862-700-20 20 TABLET in 1 BOTTLE (65862-700-20) 65862-700-60 60 TABLET in 1 BOTTLE (65862-700-60)

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": "5716a24a-653f-488a-bb44-85abffcbf92c", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309095", "309097", "309098"], "spl_set_id": ["faef39e9-d793-4191-a728-310f6fab759d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (65862-700-20)", "package_ndc": "65862-700-20", "marketing_start_date": "20060329"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65862-700-60)", "package_ndc": "65862-700-60", "marketing_start_date": "20060329"}], "brand_name": "Cefuroxime Axetil", "product_id": "65862-700_5716a24a-653f-488a-bb44-85abffcbf92c", "dosage_form": "TABLET", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "65862-700", "generic_name": "Cefuroxime Axetil", "labeler_name": "Aurobindo Pharma Limited", "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": "20060329", "listing_expiration_date": "20261231"}