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Active ingredient

Ketoconazole

76 finished FDA listings contain Ketoconazole as their only active ingredient; 1 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
KETOCONAZOLE, LEVOKETOCONAZOLE
Dosage forms
Aerosol, Foam, Cream, Liquid, Shampoo, Shampoo, Suspension, Soap, Tablet
Routes
Cutaneous, Oral, Topical
Manufacturers / labelers
43
Strengths listed
.01 g/ml · 1 g/100g · 1 g/100ml · 1 mg/100ml · 10 mg/1000g · 10 mg/ml · 150 mg/1 · 2 g/100g · 20 mg/g · 20 mg/ml · 200 mg/1
Brand names in FDA listings
1% Ketoconazole, 1% Ketoconazole Anti Dandruff, Anti Dandruff, Anti-Dandruff, Anti-Fungal, Cysndra Ketoconazole 1% Medicated Shampoos, Gemachlich Zuhause Ketoconazole 1% Anti-Dandruff Shampoos, Gembooxt Ketoconazole 1% Medicated Shampoos, Ketoconazole, Ketoconclear Cream, Ketodan, Nizoral, Recorlev, Sent From Earth Vita Scalp Revive, Tagrit Antifungal Treament Ketoconazole 1%

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6135

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 020310KRAMER1997-10-103
ANDA 075319TARO1999-06-154
ANDA 075581TEVA2000-04-254
ANDA 075912SENORES PHARMS2002-01-106
ANDA 075638SUN PHARMA CANADA2002-12-187
ANDA 076419PADAGIS ISRAEL2004-01-077
ANDA 076294FOUGERA PHARMS2004-04-281
ANDA 076942COSETTE PHARMS NC2005-04-117
ANDA 091550PADAGIS ISRAEL2011-08-257
ANDA 210457STRIDES PHARMA2018-06-182
ANDA 212443ENCUBE2021-05-209
ANDA 213601XIROMED2021-05-211
NDA 214133STRONGBRIDGE2021-12-301
ANDA 218498NOVITIUM PHARMA2024-09-161
ANDA 218559ZYDUS LIFESCIENCES2025-03-072

Official labeling on DailyMed

Showing the 12 most recent of 73 labels.

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