SPL Set ID: a4edba76-29b8-41fb-bf0b-d4633abba003
1 drug(s) with this SPL Set ID
Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are: C 16 H 21 NO 2 ·HCl Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol). Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol). Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol). Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol). The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar spheres, talc, and titanium dioxide. In addition, the 60 mg and 80 mg capsule shells contain yellow iron oxide. The 120 mg capsule shells contain black iron oxide and yellow iron oxide. The 160 mg capsule shells contain black iron oxide. The ink ingredients are common for all strengths: Opacode S-1-8114 or Opacode S-1-8115 black contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide. Meets USP Dissolution Test 7. d07a4e7b-figure-01