Xopenex (levalbuterol HCI) Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist (see CLINICAL PHARMACOLOGY). The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:

The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C₁₃H₂₁NO₃•HCI. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water.

Levalbuterol HCI is the USAN modified name for (R)-albuterol HCI in the United States.

Xopenex (levalbuterol HCI) Inhalation Solution is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit- dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCI) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCI) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCI), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).

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