SPL Set ID: 5fba93fc-4580-48c2-a1ec-5d446680adcf
1 drug(s) with this SPL Set ID
Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure: Labetalol hydrochloride, USP has the molecular formula C 19 H 24 N 2 O 3 •HCl and a molecular weight of 364.87. 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, soluble in water and in alcohol. Insoluble in ether and in chloroform. Labetalol hydrochloride tablets, USP for oral administration, contains 100 mg, 200 mg or 300 mg of labetalol hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, opadry white, polysorbate, and sodium starch glycolate (potato). Opadry white contains hypromellose, polyethylene glycol, titanium dioxide, and talc. labetalol-spl-strc