Levalbuterol Tartrate

Prevents bronchospasm. Sold as Xopenex Hfa. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Levalbuterol Tartrate (sold as Xopenex Hfa), first approved Mar 11, 2005, with 1 new use approved and 0 published complete response letters.

First approved: Mar 11, 2005
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $18.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Levalbuterol Tartrate HFA	Part D	$17.7M	+8%	102,782
Xopenex HFA	Part D	$1.2M	-22%	4,125

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LEVALBUTEROL 0.31 MG/3 ML SOL: $0.255 per MLGeneric · +4% in a year
LEVALBUTEROL 0.63 MG/3 ML SOL: $0.255 per MLGeneric · +7% in a year
LEVALBUTEROL 1.25 MG/3 ML SOL: $0.274 per MLGeneric · +3% in a year
XOPENEX HFA 45 MCG INHALER: $4.98 per GMBrand · +4% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Clearance in Primary Ciliary DyskinesiaPrimary Ciliary Dyskinesia, PCD · University of North Carolina, Chapel Hill	Not applicable	Not yet recruiting	Jul 13, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Mar 11, 2005	Xopenex HfaNDA 21730 · New dosage form	Lupin	13	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA