Escitalopram 10 MG Oral Tablet
1 INDICATIONS AND USAGE Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for the: Treatment of Major Depressive Disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of Generalized Anxiety Disorder (GAD) in adults ( 1 ) Escitalopram tablet is indicated for the treatment of: Major Depressive Disorder (MDD) in adults and pediatric patients 12 years of age and older. Generalized Anxiety Disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Accord Healthcare Inc.
ROUND WHITE 10
10 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Tablets 5 mg Tablets: Bottle of 30’s count with child-resistant closure NDC 16729-168-10 Bottle of 100’s count with child-resistant closure NDC 16729-168-01 Bottle of 500’s count NDC 16729-168-16 Bottle of 1,000’s count with child-resistant closure NDC 16729-168-17 10 x 10 Unit Dose NDC 16729-168-43 white to off-white, round, biconvex, film coated tablets, debossed with “5” on one side and plain on other side. 10 mg Tablets: Bottle of 30’s count with child-resistant closure NDC 16729-169-10 Bottle of 100’s count with child-resistant closure NDC 16729-169-01 Bottle of 500’s count NDC 16729-169-16 Bottle of 1,000’s count with child-resistant closure NDC 16729-169-17 10 x 10 Unit Dose NDC 16729-169-43 white to off-white, round, biconvex, film -coated tablets, debossed with "10” on one side and break line on other side. 20 mg Tablets: Bottle of 30’s count with child-resistant closure NDC 16729-170-10 Bottle of 100’s count with child-resistant closure NDC 16729-170-01 Bottle of 500’s count NDC 16729-170-16 Bottle of 1,000’s count with child-resistant closure NDC 16729-170-17 10 x 10 Unit Dose NDC 16729-170-43 white to off-white, round, biconvex, film coated tablets, debossed with “20” on one side and break line on other side. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
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