Active ingredient
Levocetirizine
85 finished FDA listings contain Levocetirizine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Dosage forms
- Solution, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 54
- Strengths listed
- .5 mg/ml · 2.5 mg/5ml · 5 mg/1
- Brand names in FDA listings
- 24hr Allergy Relief, Allergy Relief, Allergy Relief 24hr, Basic Care Allergy Relief, Childrens Xyzal Allergy, Curist Allergy Relief, Dg Health Allergy Relief, Good Sense Levocetirizine, Goodmeds Levocetirizine Dihydrochloride 5mg 365 Count, Topcare All Day Allergy, Xyzal, Xyzal Allergy 24hr
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 356887
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 022064 | CHATTEM SANOFI | 2007-05-25 | 2 |
| ANDA 090392 | DR REDDYS LABS LTD | 2011-02-24 | 1 |
| ANDA 090385 | GLENMARK PHARMS LTD | 2011-02-24 | 3 |
| ANDA 090199 | TEVA PHARMS | 2011-08-22 | 4 |
| ANDA 091263 | PADAGIS US | 2011-11-07 | 3 |
| ANDA 091264 | HETERO LABS LTD III | 2012-06-29 | 6 |
| ANDA 202046 | MICRO LABS LTD INDIA | 2013-09-17 | 5 |
| ANDA 203646 | SCIEGEN PHARMS | 2014-09-09 | 16 |
| ANDA 205564 | MACLEODS PHARMS | 2016-01-11 | 3 |
| NDA 209089 | CHATTEM SANOFI | 2017-01-31 | 3 |
| NDA 209090 | CHATTEM SANOFI | 2017-01-31 | 2 |
| ANDA 204599 | CHARTWELL MOLECULAR | 2017-05-15 | 1 |
| ANDA 210375 | DR REDDYS | 2018-01-19 | 16 |
| ANDA 211551 | SANKALP LIFECARE | 2018-11-20 | 2 |
| ANDA 211983 | PERRIGO R AND D | 2019-03-28 | 8 |
| ANDA 210914 | HETERO LABS LTD III | 2019-04-01 | 1 |
| ANDA 213513 | HETERO LABS LTD III | 2020-04-29 | 9 |
Official labeling on DailyMed
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] · version 20 · 2026-09-10
- ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-19
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 3 · 2026-08-17
- GOOD SENSE LEVOCETIRIZINE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY] · version 3 · 2026-07-15
- GOODMEDS LEVOCETIRIZINE DIHYDROCHLORIDE 5MG 365 COUNT (LEVOCETIRIZINE DIHYDROCHLORIDE 5MG) TABLET [CABINET HEALTH P.B.C.] · version 1 · 2026-06-30
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR. REDDY'S LABORATORIES INC.] · version 15 · 2026-06-26
- CHILDRENS XYZAL ALLERGY (LEVOCETIRIZINE DIHYDROCHLORIDE) SOLUTION [CHATTEM, INC.] · version 23 · 2026-06-08
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 102 · 2026-05-25
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [FARMACIAS DE SIMILARES TX LLC] · version 1 · 2026-05-20
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-05-20
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-04-02
- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-03-26
Showing the 12 most recent of 79 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.