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Active ingredient

Cefazolin

48 finished FDA listings contain Cefazolin as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
CEFAZOLIN, CEFAZOLIN SODIUM
Dosage forms
Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Powder, For Solution, Solution
Routes
Intramuscular, Intravenous, Parenteral
Manufacturers / labelers
18
Strengths listed
1 g/1 · 1 g/3ml · 1 g/50ml · 10 g/1 · 100 g/1 · 2 g/1 · 2 g/100ml · 2 g/50ml · 20 g/1 · 225 mg/ml · 3 g/1 · 3 g/150ml · 3 g/50ml · 300 g/1 · 330 mg/ml · 500 mg/1 · 500 mg/2.2ml
Brand names in FDA listings
Cefazolin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2180

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 062831SANDOZ1988-12-093
NDA 050779B BRAUN2000-07-273
ANDA 065047HIKMA FARMACEUTICA2001-09-188
ANDA 065143HIKMA FARMACEUTICA2004-10-184
ANDA 065141SAMSON MEDCL2006-11-292
ANDA 065345SANDOZ2007-05-091
ANDA 065303ACS DOBFAR2008-10-225
ANDA 065306ACS DOBFAR2008-10-222
NDA 207131BAXTER HLTHCARE CORP2015-08-073
ANDA 203661QILU ANTIBIOTICS2015-12-2810
ANDA 209217QILU ANTIBIOTICS2018-10-172
NDA 216109HIKMA2022-10-073
NDA 211413HQ SPCLT PHARMA2023-05-082

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

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