Active ingredient
Levalbuterol
36 finished FDA listings contain Levalbuterol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL TARTRATE
- Dosage forms
- Aerosol, Metered, Solution, Solution, Concentrate
- Routes
- Oral, Respiratory (Inhalation)
- Manufacturers / labelers
- 14
- Strengths listed
- .31 mg/3ml · .63 mg/3ml · 1.25 mg/.5ml · 1.25 mg/3ml · 45 ug/1
- Brand names in FDA listings
- Levalbuterol, Levalbuterol Tartrate Hfa Inhalation, Xopenex Hfa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 237159
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 021730 | LUPIN | 2005-03-11 | 3 |
| ANDA 078309 | MYLAN SPECIALITY LP | 2009-03-20 | 1 |
| ANDA 090297 | TEVA PHARMS USA | 2013-04-26 | 4 |
| ANDA 203653 | RITEDOSE CORP | 2016-03-22 | 18 |
| ANDA 207625 | LUOXIN AUROVITAS | 2016-12-30 | 6 |
| ANDA 207628 | LUOXIN AUROVITAS | 2017-01-31 | 1 |
| ANDA 207820 | SUN PHARM | 2018-11-05 | 3 |
Official labeling on DailyMed
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REDPHARM DRUG] · version 1 · 2026-08-12
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REDPHARM DRUG] · version 1 · 2026-07-20
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] · version 22 · 2025-12-12
- XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [LUPIN PHARMACEUTICALS, INC.] · version 3 · 2025-07-30
- LEVALBUTEROL SOLUTION [LUOXIN AUROVITAS PHARMA (CHENGDU) CO., LTD.] · version 1 · 2024-12-26
- LEVALBUTEROL SOLUTION [AUROBINDO PHARMA LIMITED] · version 8 · 2024-12-26
- LEVALBUTEROL (LEVALBUTEROL) SOLUTION, CONCENTRATE [AUROBINDO PHARMA LIMITED] · version 6 · 2023-10-31
- LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE) AEROSOL, METERED [ACTAVIS PHARMA, INC.] · version 20 · 2023-10-26
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK] · version 100 · 2023-09-18
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK] · version 100 · 2023-09-18
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK] · version 100 · 2023-09-18
- LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BUREL PHARMACEUTICALS, LLC] · version 9 · 2023-06-13
Showing the 12 most recent of 20 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.