cefuroxime axetil

Generic: cefuroxime axetil

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-283
Product ID 60687-283_3bb8ed50-e786-f167-e063-6294a90a6031
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065496
Listing Expiration 2026-12-31
Marketing Start 2023-06-26

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687283
Hyphenated Format 60687-283

Supplemental Identifiers

RxCUI
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 ANDA065496 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (60687-283-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-283-11)
source: ndc

Packages (1)

60687-283-94 20 BLISTER PACK in 1 CARTON (60687-283-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-283-11)

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": "3bb8ed50-e786-f167-e063-6294a90a6031", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309097", "309098"], "spl_set_id": ["f38418a7-dd90-4f20-b747-7ac086c53015"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (60687-283-94)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-283-11)", "package_ndc": "60687-283-94", "marketing_start_date": "20230626"}], "brand_name": "Cefuroxime axetil", "product_id": "60687-283_3bb8ed50-e786-f167-e063-6294a90a6031", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "60687-283", "generic_name": "Cefuroxime axetil", "labeler_name": "American Health Packaging", "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": "20230626", "listing_expiration_date": "20261231"}