SPL Set ID: b787a283-f882-e1f0-e053-2a95a90a8975
1 drug(s) with this SPL Set ID
Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO•HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in alcohol and methylene chloride. CHEMISTRY Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz [ b, e]oxepin-11(6 H)ylidene- N,N-dimethyl-, hydrochloride. It may be represented by the following structural formula: Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg Doxepin capsule for oral administration contains Doxepin hydrochloride equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of Doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Potassium Hydroxide and Black Iron Oxide. Meets USP Dissolution Test 3. Structure CHEMISTRY Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz [ b, e]oxepin-11(6 H)ylidene- N,N-dimethyl-, hydrochloride. It may be represented by the following structural formula: Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg Doxepin capsule for oral administration contains Doxepin hydrochloride equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of Doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Potassium Hydroxide and Black Iron Oxide. Meets USP Dissolution Test 3. Structure