cefuroxime axetil

Generic: cefuroxime axetil

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefuroxime axetil 250 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-991
Product ID 63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b
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 63187991
Hyphenated Format 63187-991

Supplemental Identifiers

RxCUI
309097
UPC
0363187991203
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
  • 250 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (63187-991-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-991-60)
source: ndc

Packages (2)

63187-991-20 20 TABLET, FILM COATED in 1 BOTTLE (63187-991-20) 63187-991-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-991-60)

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": "8251b1f4-6da1-461e-9512-fed77a1f402b", "openfda": {"upc": ["0363187991203"], "unii": ["Z49QDT0J8Z"], "rxcui": ["309097"], "spl_set_id": ["e9a020ec-e446-469a-b1d1-07e82eefa305"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (63187-991-20)", "package_ndc": "63187-991-20", "marketing_start_date": "20180301"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-991-60)", "package_ndc": "63187-991-60", "marketing_start_date": "20101201"}], "brand_name": "Cefuroxime axetil", "product_id": "63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "63187-991", "generic_name": "Cefuroxime axetil", "labeler_name": "Proficient Rx LP", "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"}