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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021165 | ORGANON | 2001-12-21 | 2 |
| ANDA 078357 | ORBION PHARMS | 2010-02-19 | 1 |
| ANDA 078367 | REDDYS | 2010-07-12 | 2 |
| ANDA 078352 | LUPIN PHARMS | 2010-10-25 | 4 |
| ANDA 078351 | NATCO PHARMA USA | 2012-02-10 | 1 |
| ANDA 078355 | AJENAT PHARMS | 2012-04-19 | 4 |
| ANDA 202936 | TARO | 2016-05-26 | 1 |
Official labeling on DailyMed
- DESLORATADINE TABLET [MOREPEN BIO INC.] · version 1 · 2026-08-28
- DESLORATADINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] · version 17 · 2026-07-03
- DESLORATADINE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 5 · 2026-06-03
- DESLORATADINE TABLET, FILM COATED [NATCO PHARMA USA LLC] · version 1 · 2026-04-27
- DESLORATADINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 12 · 2026-04-17
- DESLORATADINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 3 · 2026-04-17
- DESLORATADINE TABLET [BRYANT RANCH PREPACK] · version 102 · 2025-11-17
- DESLORATADINE ORAL SOLUTION (DESLORATADINE) SOLUTION [INA PHARMACEUTICS, INC.] · version 1 · 2025-11-17
- DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS, LLC] · version 7 · 2025-07-14
- CLARINEX (DESLORATADINE) TABLET, FILM COATED [ORGANON LLC] · version 6 · 2025-05-28
- DESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED] · version 10 · 2024-05-30
- DESLORATADINE TABLET [A-S MEDICATION SOLUTIONS] · version 8 · 2023-12-13
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.