Trazodone Hydrochloride 50 MG Oral Tablet
INDICATIONS AND USAGE Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association's Diagnostic and Statistical Manual, III. a Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
Keltman Pharmaceuticals Inc.
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HOW SUPPLIED Trazodone hydrochloride tablets USP, 50 mg are round, white, film-coated, single scored tablets debossed "93" – "637". Trazodone hydrochloride tablets USP, 100 mg are round, white, film-coated, single scored tablets debossed "93" – "638". They are supplied by Keltman Pharmaceuticals Inc. as follows: NDC Strength Quantity/Form Color Source Prod. Code 68387-165-30 50 mg 30 Tablets in a Plastic Bottle white 0603-6147 68387-165-60 50 mg 60 Tablets in a Plastic Bottle white 0603-6147 68387-165-90 50 mg 90 Tablets in a Plastic Bottle white 0603-6147 68387-166-30 100 mg 30 Tablets in a Plastic Bottle white 0603-6148
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