venlafaxine 75 MG as venlafaxine hydrochloride 84.9 MG Oral Tablet
INDICATIONS AND USAGE Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS ). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
aurobindo pharma limited
ROUND ORANGE I 21
I 21 ROUND ORANGE
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HOW SUPPLIED Venlafaxine Tablets USP, 25 mg are peach colored, circular, biconvex, uncoated tablets debossed with ‘I’ and breakline on one side and ‘17’ on the other side. Bottles of 30 NDC 65862-404-30 Bottles of 60 NDC 65862-404-60 Bottles of 90 NDC 65862-404-90 Bottles of 100 NDC 65862-404-01 Bottles of 1,000 NDC 65862-404-99 Bottles of 7,000 NDC 65862-404-71 10 x 10 Unit-dose Tablets NDC 65862-404-10 Venlafaxine Tablets USP, 37.5 mg are peach colored, circular, biconvex, uncoated tablets debossed with ‘I’ and breakline on one side and ‘19’ on the other side. Bottles of 30 NDC 65862-405-30 Bottles of 60 NDC 65862-405-60 Bottles of 90 NDC 65862-405-90 Bottles of 100 NDC 65862-405-01 Bottles of 1,000 NDC 65862-405-99 Bottles of 6,000 NDC 65862-405-66 10 x 10 Unit-dose Tablets NDC 65862-405-10 Venlafaxine Tablets USP , 50 mg are peach colored, circular, biconvex, uncoated tablets debossed with ‘I’ and breakline on one side and ‘20’ on the other side. Bottles of 30 NDC 65862-406-30 Bottles of 90 NDC 65862-406-90 Bottles of 100 NDC 65862-406-01 Bottles of 1,000 NDC 65862-406-99 Bottles of 5,000 NDC 65862-406-59 10 x 10 Unit-dose Tablets NDC 65862-406-10 Venlafaxine Tablets USP , 75 mg are peach colored, circular, biconvex, uncoated tablets debossed with ‘I’ and breakline on one side and ‘21’ on the other side. Bottles of 30 NDC 65862-407-30 Bottles of 90 NDC 65862-407-90 Bottles of 100 NDC 65862-407-01 Bottles of 1,000 NDC 65862-407-99 Bottles of 7,000 NDC 65862-407-71 10 x 10 Unit-dose Tablets NDC 65862-407-10 Venlafaxine Tablets USP , 100 mg are peach colored, circular, biconvex, uncoated tablets debossed with ‘I’ and breakline on one side and ‘22’ on the other side. Bottles of 20 NDC 65862-408-20 Bottles of 90 NDC 65862-408-90 Bottles of 100 NDC 65862-408-01 Bottles of 1,000 NDC 65862-408-99 Bottles of 6,000 NDC 65862-408-66 10 x 10 Unit-dose Tablets NDC 65862-408-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 08/2023 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides.
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