cefuroxime

Generic: cefuroxime

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefuroxime
Generic Name cefuroxime
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cefuroxime sodium 750 mg/8mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9976
Product ID 0143-9976_5621cde0-74c5-45b2-8f76-329eb22b4a0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065046
Listing Expiration 2026-12-31
Marketing Start 2004-01-09

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439976
Hyphenated Format 0143-9976

Supplemental Identifiers

RxCUI
309101
UNII
R8A7M9MY61

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 (source: ndc)
Generic Name cefuroxime (source: ndc)
Application Number ANDA065046 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 750 mg/8mL
source: ndc
Packaging
  • 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9976-03) / 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0143-9976-91)
source: ndc

Packages (1)

0143-9976-03 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9976-03) / 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0143-9976-91)

Ingredients (1)

cefuroxime sodium (750 mg/8mL)

Linked Drug Pages (1)

Cefuroxime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5621cde0-74c5-45b2-8f76-329eb22b4a0a", "openfda": {"unii": ["R8A7M9MY61"], "rxcui": ["309101"], "spl_set_id": ["65daa2aa-cc4a-4eba-b7dc-7a151806865a"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9976-03)  / 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0143-9976-91)", "package_ndc": "0143-9976-03", "marketing_start_date": "20040109"}], "brand_name": "Cefuroxime", "product_id": "0143-9976_5621cde0-74c5-45b2-8f76-329eb22b4a0a", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0143-9976", "generic_name": "Cefuroxime", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefuroxime", "active_ingredients": [{"name": "CEFUROXIME SODIUM", "strength": "750 mg/8mL"}], "application_number": "ANDA065046", "marketing_category": "ANDA", "marketing_start_date": "20040109", "listing_expiration_date": "20261231"}