SPL Set ID: 27d6c9c5-5a45-9cfc-e063-6394a90a7202
1 drug(s) with this SPL Set ID
Nifedipine extended-release tablets, USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine USP is a yellow powder, practically insoluble in water, freely soluble in acetone and sparingly soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain either: 30 mg, 60 mg, or 90 mg of nifedipine USP for once-a-day oral administration. Inert ingredients are: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol and titanium dioxide. In addition 30 mg and 60 mg tablets contain FD&C Yellow 5 (tartrazine) aluminum lake and FD&C Yellow 6 aluminum lake, 90 mg tablets contain FD&C Red 40 aluminum lake and 30 mg and 90 mg tablets contain FD&C Blue 2 aluminum lake. FDA approved dissolution test specifications differ from USP. Chemical Strucure