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Active ingredient

Cefuroxime

51 finished FDA listings contain Cefuroxime as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CEFUROXIME AXETIL, CEFUROXIME SODIUM
Dosage forms
Injection, Powder, For Solution, Injection, Solution, Tablet, Tablet, Film Coated
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
20
Strengths listed
1.5 g/1 · 1.5 g/20ml · 1.5 g/50ml · 125 mg/1 · 250 mg/1 · 500 mg/1 · 7.5 g/1 · 750 mg/1 · 750 mg/50ml · 750 mg/8ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2194

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 064125ACS DOBFAR SPA1997-05-302
NDA 050780B BRAUN2001-02-212
ANDA 065048HIKMA2004-01-094
ANDA 065046HIKMA2004-01-092
ANDA 065308AUROBINDO PHARMA2006-03-2922
ANDA 065496ALKEM LABS LTD2010-06-0719

Official labeling on DailyMed

Showing the 12 most recent of 38 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.