cefuroxime axetil

Generic: cefuroxime axetil

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime axetil
Generic Name cefuroxime axetil
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cefuroxime axetil 500 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-401
Product ID 16714-401_c89c84c5-710f-4a4a-8171-c38bee355c1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065308
Listing Expiration 2026-12-31
Marketing Start 2006-03-29

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714401
Hyphenated Format 16714-401

Supplemental Identifiers

RxCUI
309097 309098
UPC
0316714401010 0316714400013
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 ANDA065308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (16714-401-01)
  • 60 TABLET in 1 BOTTLE (16714-401-02)
source: ndc

Packages (2)

16714-401-01 20 TABLET in 1 BOTTLE (16714-401-01) 16714-401-02 60 TABLET in 1 BOTTLE (16714-401-02)

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": "c89c84c5-710f-4a4a-8171-c38bee355c1f", "openfda": {"upc": ["0316714401010", "0316714400013"], "unii": ["Z49QDT0J8Z"], "rxcui": ["309097", "309098"], "spl_set_id": ["fd79c41e-b0e9-47dc-a3ce-caacdc66bc96"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (16714-401-01)", "package_ndc": "16714-401-01", "marketing_start_date": "20060329"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (16714-401-02)", "package_ndc": "16714-401-02", "marketing_start_date": "20060329"}], "brand_name": "Cefuroxime Axetil", "product_id": "16714-401_c89c84c5-710f-4a4a-8171-c38bee355c1f", "dosage_form": "TABLET", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "16714-401", "generic_name": "Cefuroxime Axetil", "labeler_name": "NorthStar Rx LLC", "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": "20060329", "listing_expiration_date": "20261231"}