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Active ingredient

Desloratadine

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

FDA NDC Directory

Ingredient names as written by FDA
DESLORATADINE
Dosage forms
Solution, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
10
Strengths listed
.5 mg/ml · 2.5 mg/1 · 5 mg/1
Brand names in FDA listings
Clarinex, Desloratadine Oral Solution

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 275635

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 021165ORGANON2001-12-212
ANDA 078357ORBION PHARMS2010-02-191
ANDA 078367REDDYS2010-07-122
ANDA 078352LUPIN PHARMS2010-10-254
ANDA 078351NATCO PHARMA USA2012-02-101
ANDA 078355AJENAT PHARMS2012-04-194
ANDA 202936TARO2016-05-261

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

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