cefuroxime axetil

Generic: cefuroxime axetil

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-059
Product ID 57237-059_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8
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 57237059
Hyphenated Format 57237-059

Supplemental Identifiers

RxCUI
309097 309098
UPC
0357237059203
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, FILM COATED in 1 BOTTLE (57237-059-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE (57237-059-60)
source: ndc

Packages (2)

57237-059-20 20 TABLET, FILM COATED in 1 BOTTLE (57237-059-20) 57237-059-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-059-60)

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": "d7e9c50b-74c7-4c0b-9c73-8802fa288cd8", "openfda": {"upc": ["0357237059203"], "unii": ["Z49QDT0J8Z"], "rxcui": ["309097", "309098"], "spl_set_id": ["66f8d37f-aebc-4435-af80-dfd7b3770088"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (57237-059-20)", "package_ndc": "57237-059-20", "marketing_start_date": "20060329"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (57237-059-60)", "package_ndc": "57237-059-60", "marketing_start_date": "20060329"}], "brand_name": "Cefuroxime Axetil", "product_id": "57237-059_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "57237-059", "generic_name": "Cefuroxime Axetil", "labeler_name": "Rising Pharma Holdings, 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": "20060329", "listing_expiration_date": "20261231"}