SPL Set ID: 04a85be5-f746-418e-8e37-292703f16934
1 drug(s) with this SPL Set ID
Diltiazem hydrochloride, USP is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5 H )one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Its molecular formula is C 22 H 26 N 2 O 4 S•HCl and its molecular weight is 450.98. Its structural formula is as follows: Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, formic acid, methanol and water, sparingly soluble in dehydrated ethanol and insoluble in ether. Diltiazem hydrochloride extended-release capsules, USP contain 120 mg or 180 mg or 240 mg diltiazem hydrochloride and are formulated for the controlled release of diltiazem hydrochloride over a 24-hour period. Inactive Ingredients: Diltiazem hydrochloride extended-release capsules, USP contain lactose monohydrate, hypromellose, colloidal silicon dioxide and magnesium stearate. The 120 mg, 180 mg and 240 mg capsule shells contain FD&C Blue 1, FD&C Red 3, FD&C Red 40, titanium dioxide and gelatin. Additionally, 120 mg capsule shell contains FD&C Yellow 6, 180 mg and 240 mg capsule shell contains D&C Red 33. The capsules are printed with edible ink containing shellac, iron oxide black and potassium hydroxide. For oral administration. FDA approved dissolution test specifications differ from USP. diltiazem-str.jpg