cefuroxime axetil

Generic: cefuroxime axetil

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 250 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7542
Product ID 0904-7542_8f3e739a-07d6-48a6-812f-49e049048bd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065496
Listing Expiration 2026-12-31
Marketing Start 2025-08-25

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047542
Hyphenated Format 0904-7542

Supplemental Identifiers

RxCUI
309097
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
  • 250 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0904-7542-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7542-10 2 BLISTER PACK in 1 CARTON (0904-7542-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

cefuroxime axetil (250 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": "8f3e739a-07d6-48a6-812f-49e049048bd3", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309097"], "spl_set_id": ["44e1fb4d-4b61-40da-9974-0bd2006eb828"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0904-7542-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7542-10", "marketing_start_date": "20250825"}], "brand_name": "Cefuroxime axetil", "product_id": "0904-7542_8f3e739a-07d6-48a6-812f-49e049048bd3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0904-7542", "generic_name": "Cefuroxime axetil", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefuroxime axetil", "active_ingredients": [{"name": "CEFUROXIME AXETIL", "strength": "250 mg/1"}], "application_number": "ANDA065496", "marketing_category": "ANDA", "marketing_start_date": "20250825", "listing_expiration_date": "20261231"}