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Active ingredient

Ciclopirox

39 finished FDA listings contain Ciclopirox as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CICLOPIROX, CICLOPIROX OLAMINE
Dosage forms
Cream, Gel, Shampoo, Solution, Suspension
Routes
Topical
Manufacturers / labelers
14
Strengths listed
1 g/100ml · 10 mg/.96ml · 7.7 mg/100ml · 7.7 mg/g · 7.7 mg/ml · 71.3 mg/ml · 80 mg/ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 21090

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 076790SUN PHARMA CANADA2005-04-121
ANDA 077364PADAGIS ISRAEL2006-03-036
ANDA 077676PADAGIS ISRAEL2006-12-156
ANDA 078046CHARTWELL RX2007-09-181
ANDA 077687ENCUBE2007-09-184
ANDA 077623PADAGIS US2007-09-184
ANDA 078172ACELLA2007-09-183
ANDA 078266PADAGIS US2009-01-075
ANDA 090273GLENMARK PHARMS2009-11-102
ANDA 090490ACTAVIS MID ATLANTIC2009-11-241
ANDA 078594PADAGIS US2010-02-161
ANDA 078463COSETTE PHARMS NC2010-12-201
ANDA 090269SUN PHARMA CANADA2011-02-231
ANDA 091595GLENMARK PHARMS2012-02-292
ANDA 209975ENCUBE2018-04-051

Official labeling on DailyMed

Showing the 12 most recent of 39 labels.

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