NDC 0143-9979

Cefuroxime

Cefuroxime

Cefuroxime is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Cefuroxime Sodium.

Product ID0143-9979_5f10e284-5a3c-405f-813c-d063dd655f7f
NDC0143-9979
Product TypeHuman Prescription Drug
Proprietary NameCefuroxime
Generic NameCefuroxime
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2004-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA065048
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameCEFUROXIME SODIUM
Active Ingredient Strength750 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-9979-22

25 VIAL in 1 CARTON (0143-9979-22) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9979-90)
Marketing Start Date2004-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9979-22 [00143997922]

Cefuroxime INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-01-09

NDC 0143-9979-90 [00143997990]

Cefuroxime INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-15

Drug Details

Active Ingredients

IngredientStrength
CEFUROXIME SODIUM750 mg/1

OpenFDA Data

SPL SET ID:703cc338-c0b6-4a02-b8db-c27aeff181df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665444
  • 1665449
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]
    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefuroxime" or generic name "Cefuroxime"

    NDCBrand NameGeneric Name
    0143-9567CefuroximeCefuroxime
    0143-9568CefuroximeCefuroxime
    0143-9569CefuroximeCefuroxime
    0143-9976CefuroximeCefuroxime
    0143-9977CefuroximeCefuroxime
    0143-9979CefuroximeCefuroxime
    44567-710CefuroximeCefuroxime
    44567-711CefuroximeCefuroxime
    44567-712CefuroximeCefuroxime
    44567-720CefuroximeCefuroxime
    44567-722CefuroximeCefuroxime

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.