cefuroxime axetil

Generic: cefuroxime axetil

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 250 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-215
Product ID 67877-215_7c9fa966-9491-40a8-a57b-6f60dbf7bb55
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 67877215
Hyphenated Format 67877-215

Supplemental Identifiers

RxCUI
309097 309098
UPC
0367877216607
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
  • 100 TABLET, FILM COATED in 1 BOTTLE (67877-215-01)
  • 20 TABLET, FILM COATED in 1 BOTTLE (67877-215-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE (67877-215-60)
  • 30 BLISTER PACK in 1 CARTON (67877-215-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

67877-215-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-215-01) 67877-215-20 20 TABLET, FILM COATED in 1 BOTTLE (67877-215-20) 67877-215-60 60 TABLET, FILM COATED in 1 BOTTLE (67877-215-60) 67877-215-84 30 BLISTER PACK in 1 CARTON (67877-215-84) / 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": "7c9fa966-9491-40a8-a57b-6f60dbf7bb55", "openfda": {"upc": ["0367877216607"], "unii": ["Z49QDT0J8Z"], "rxcui": ["309097", "309098"], "spl_set_id": ["dd11e4b9-7730-4d3a-81ca-16f15de09759"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-215-01)", "package_ndc": "67877-215-01", "marketing_start_date": "20101201"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (67877-215-20)", "package_ndc": "67877-215-20", "marketing_start_date": "20101201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (67877-215-60)", "package_ndc": "67877-215-60", "marketing_start_date": "20101201"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (67877-215-84)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-215-84", "marketing_start_date": "20101201"}], "brand_name": "Cefuroxime axetil", "product_id": "67877-215_7c9fa966-9491-40a8-a57b-6f60dbf7bb55", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "67877-215", "generic_name": "Cefuroxime axetil", "labeler_name": "Ascend Laboratories, LLC", "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": "20101201", "listing_expiration_date": "20261231"}