Source: FDA, National Drug Code (US) Revision Year: 2023
Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2, 6-dimethyl-3, 5-pyridinedicarboxylate. Its empirical formula is C 18H 19Cl 2NO 4 and its structural formula is:
Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.
Felodipine Extended-release Tablets, USP provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration.
Inactive ingredients for core tablets are: anhydrous lactose, butylated hydroxyanisole, butylated hydroxytoluene, colloidal silicon dioxide, hypromellose, polyoxyl 40 hydrogenated castor oil, microcrystalline cellulose, povidone K30 and sodium stearyl fumarate.
Film coating materials of 2.5 mg: ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, maltodextrin, medium chain triglycerides, polydextrose, talc and titanium dioxide.
Film coating materials of 5 mg: ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, maltodextrin, medium chain triglycerides, polydextrose, talc and titanium dioxide.
Film coating materials of 10 mg: ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, maltodextrin, medium chain triglycerides, polydextrose, talc and titanium dioxide.
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Felodipine Extended-release Tablets, USP 2.5 mg, are yellow film-coated, round convex tablets, with code Y161 on one side. They are supplied as follows: NDC 69117-0028-1 bottles of 100 Felodipine Extended-release Tablets, USP 5 mg, are pink film-coated, round convex tablets, with code Y162 on one side. They are supplied as follows: NDC 69117-0029-1 bottles of 100’s Felodipine Extended-release Tablets, USP 10 mg, are red film-coated, round convex tablets, with code Y163 on one side. They are supplied as follows: NDC 69117-0030-1 bottles of 100’s Manufacturer: Yiling Pharmaceutical Ltd, No. 36 Zhujiang Road, Shijiazhuang, Hebei, 050035, China Distributor: Yiling Pharmaceutical, Inc., 5348 Vegas Drive, Las Vegas, NV 89108, USA |
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