Skip to content
LookupMeds

Active ingredient

Itraconazole

15 finished FDA listings contain Itraconazole as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
ITRACONAZOLE
Dosage forms
Capsule, Capsule, Coated Pellets, Capsule, Gelatin Coated, Solution
Routes
Oral
Manufacturers / labelers
14
Strengths listed
10 mg/ml · 100 mg/1 · 65 mg/1
Brand names in FDA listings
Itraconazole Oral, Sporanox, Tolsura

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 28031

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 020083JANSSEN PHARMS1992-09-112
ANDA 205573AMNEAL PHARMS2015-10-301
ANDA 205080AMNEAL PHARMS2016-09-263
ANDA 206741ALEMBIC2016-12-132
ANDA 205724RISING2016-12-131
ANDA 208591ALKEM LABS LTD2017-06-122
ANDA 209460TORRENT2018-08-241
NDA 208901MAYNE PHARMA2018-12-111
ANDA 212239ANNORA PHARMA2020-09-012

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

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