Ranitidine Tablets USP Revised: June 2005 Rx only
DESCRIPTION
Ranitidine hydrochloride (HCl) is a histamine H2-receptor antagonist. Chemically it is N -[ 2-[[[5-[(Dimethylamino)methyl]-2-furanyl] methyl]thio]ethyl]- N' -methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:
The empirical formula is C13H22N4O3S·HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor.
Each tablet, for oral administration, contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine, or 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium bicarbonate, synthetic red iron oxide, synthetic yellow iron oxide, talc, titanium dioxide and triethyl citrate.
|