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Active ingredient

Fluconazole

162 finished FDA listings contain Fluconazole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FLUCONAZOLE
Dosage forms
Injection, Injection, Solution, Powder, For Suspension, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
44
Strengths listed
10 mg/ml · 100 mg/1 · 1400 mg/35ml · 150 mg/1 · 2 mg/ml · 200 mg/1 · 200 mg/100ml · 40 mg/ml · 400 mg/200ml · 50 mg/1
Brand names in FDA listings
Diflucan

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4450

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 020090PFIZER1993-12-233
ANDA 076665CHARTWELL2004-07-296
ANDA 076766BAXTER HLTHCARE2004-07-292
ANDA 076658DR REDDYS LABS INC2004-07-2914
ANDA 076736HIKMA FARMACEUTICA2005-08-231
ANDA 077253GLENMARK PHARMS LTD2006-01-2528
ANDA 077731AUROBINDO PHARMA2008-10-0754
ANDA 079104INFORLIFE2009-07-304
ANDA 079150AUROBINDO PHARMA2009-09-186
ANDA 078423ANI PHARMS2011-03-0717
ANDA 078698HIKMA FARMACEUTICA2012-01-302
ANDA 078764HIKMA FARMACEUTICA2012-01-302
ANDA 208963ZYDUS PHARMS2017-02-1621
ANDA 215738ZHEJIANG POLY PHARM2023-09-212

Official labeling on DailyMed

Showing the 12 most recent of 98 labels.

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