SPL Set ID: dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc

1 drug(s) with this SPL Set ID

Open DailyMed details

LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Labetalol hydrochloride is an adrenergic receptor blocking agent that has both selective alpha 1 - and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino]ethyl]salicylamide monohydrochloride and has the following structural formula: Labetalol hydrochloride has the molecular formula C 19 H 24 N 2 O 3 • HCl and a molecular weight of 364.87 g/mol. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white to off-white powder, sparingly soluble in water and in ethanol (96%), practically insoluble in methylene chloride. Labetalol hydrochloride injection, USP is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP; 45 mg anhydrous dextrose; 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range. 1

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