SPL Set ID: 206bbdec-04f0-40e3-a259-32fc6bce20d8
1 drug(s) with this SPL Set ID
Levalbuterol inhalation solution, USP (concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology (12) ] . The chemical name for levalbuterol hydrochloride is (R)-α 1 -[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows: The molecular weight of levalbuterol hydrochloride is 275.8, and its molecular formula is C 13 H 21 NO 3 •HCl. 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 hydrochloride is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol inhalation solution (concentrate) is supplied in 0.5 mL individually-wrapped unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a chelating agent and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5). Levalbuterol Hydrochloride Structural Formula