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Active ingredient

Cefdinir

78 finished FDA listings contain Cefdinir as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
CEFDINIR, CEFDINIR MONOHYDRATE
Dosage forms
Capsule, Powder, For Suspension
Routes
Oral
Manufacturers / labelers
25
Strengths listed
125 mg/5ml · 250 mg/5ml · 300 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 25037

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 065264LUPIN2006-05-194
ANDA 065259LUPIN2006-05-3112
ANDA 065330CHARTWELL RX2007-04-062
ANDA 065332TEVA PHARMS2007-05-047
ANDA 065368TEVA PHARMS2007-05-092
ANDA 065473AUROBINDO PHARMA2007-12-1412
ANDA 065434AUROBINDO PHARMA2008-01-0718
ANDA 210534ALKEM LABS LTD2021-02-196
ANDA 210220ALKEM LABS LTD2021-02-1915

Official labeling on DailyMed

Showing the 12 most recent of 70 labels.

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