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Active ingredient

Terconazole

12 finished FDA listings contain Terconazole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TERCONAZOLE
Dosage forms
Cream, Suppository
Routes
Vaginal
Manufacturers / labelers
6
Strengths listed
4 mg/g · 8 mg/g · 80 mg/1
Brand names in FDA listings
Terconazole Vaginal Cream 0.8%

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 37806

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 075953SUN PHARMA CANADA2004-04-063
NDA 021735FOUGERA2004-10-012
ANDA 076043SUN PHARMA CANADA2005-01-192
ANDA 076712FOUGERA PHARMS2005-02-182
ANDA 077149PADAGIS ISRAEL2006-03-171
ANDA 077553SUN PHARMA CANADA2007-03-092

Official labeling on DailyMed

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