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Active ingredient

Ceftriaxone

63 finished FDA listings contain Ceftriaxone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CEFTRIAXONE SODIUM
Dosage forms
Injection, Powder, For Solution, Injection, Solution
Routes
Intramuscular, Intravenous
Manufacturers / labelers
17
Strengths listed
1 g/1 · 1 g/50ml · 10 g/1 · 10 g/100ml · 100 g/1 · 2 g/1 · 2 g/50ml · 250 mg/1 · 500 mg/1
Brand names in FDA listings
Ceftriaxone, Ceftriaxone And Dextrose

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2193

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
NDA 050796B BRAUN2005-04-202
ANDA 065204SANDOZ INC2005-05-033
ANDA 065169SANDOZ2005-05-0920
ANDA 065168SANDOZ2005-05-173
ANDA 065224BAXTER HLTHCARE2005-08-232
ANDA 065342HIKMA FARMACEUTICA2008-01-106
ANDA 065329ACS DOBFAR2008-07-249
ANDA 065328ACS DOBFAR2008-07-241
ANDA 090057SAMSON MEDCL2014-04-251
ANDA 203702QILU ANTIBIOTICS2016-06-2914
ANDA 090701HIKMA2017-10-041
ANDA 209218QILU ANTIBIOTICS2018-10-171

Official labeling on DailyMed

Showing the 12 most recent of 35 labels.

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