SPL Set ID: 5f1c4f22-d420-495c-8f64-33532638215f
1 drug(s) with this SPL Set ID
Levalbuterol inhalation solution, USP 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 USP is 275.78, and its molecular formula is C 13 H 21 NO 3 •HCl. It is a white or almost white, crystalline powder, with a melting point of approximately 188 to 195°C and freely soluble in water. Levalbuterol hydrochloride is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol inhalation solution, USP 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 hydrochloride USP) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol hydrochloride USP) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride USP), edetate disodium, sodium chloride to adjust tonicity and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5). Levalbuterol Hydrochloride Chemical Structure