cefuroxime axetil

Generic: cefuroxime axetil

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-035
Product ID 72789-035_303d9134-594c-63c6-e063-6394a90a4edf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065496
Listing Expiration 2026-12-31
Marketing Start 2010-12-01

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789035
Hyphenated Format 72789-035

Supplemental Identifiers

RxCUI
309098
UPC
0372789035147
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 ANDA065496 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-60)
source: ndc

Packages (3)

72789-035-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-14) 72789-035-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20) 72789-035-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-60)

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": "303d9134-594c-63c6-e063-6394a90a4edf", "openfda": {"upc": ["0372789035147"], "unii": ["Z49QDT0J8Z"], "rxcui": ["309098"], "spl_set_id": ["15cabe73-f39d-4798-a840-115fe94f8f96"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-14)", "package_ndc": "72789-035-14", "marketing_start_date": "20230515"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20)", "package_ndc": "72789-035-20", "marketing_start_date": "20191218"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-60)", "package_ndc": "72789-035-60", "marketing_start_date": "20191218"}], "brand_name": "Cefuroxime axetil", "product_id": "72789-035_303d9134-594c-63c6-e063-6394a90a4edf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "72789-035", "generic_name": "Cefuroxime axetil", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20101201", "listing_expiration_date": "20261231"}