cefuroxime axetil

Generic: cefuroxime axetil

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cefuroxime axetil 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3215
Product ID 70518-3215_4ab61a1a-01ab-1dfa-e063-6294a90a4d37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065308
Listing Expiration 2027-12-31
Marketing Start 2021-09-08

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183215
Hyphenated Format 70518-3215

Supplemental Identifiers

RxCUI
309098
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 ANDA065308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3215-4)
source: ndc

Packages (1)

70518-3215-4 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3215-4)

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": "4ab61a1a-01ab-1dfa-e063-6294a90a4d37", "openfda": {"unii": ["Z49QDT0J8Z"], "rxcui": ["309098"], "spl_set_id": ["76cec54f-d167-4298-951b-5411a3c47f4a"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3215-4)", "package_ndc": "70518-3215-4", "marketing_start_date": "20240113"}], "brand_name": "Cefuroxime Axetil", "product_id": "70518-3215_4ab61a1a-01ab-1dfa-e063-6294a90a4d37", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "70518-3215", "generic_name": "Cefuroxime Axetil", "labeler_name": "REMEDYREPACK 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": "20210908", "listing_expiration_date": "20271231"}