escitalopram 15 mg/1

escitalopram · CAPSULE · Almatica Pharma LLC

2 Recalls on Record

Plain English

escitalopram is a capsule containing escitalopram at 15 mg/1, taken oral. Manufactured by Almatica Pharma LLC.

Key Facts

Brand Name: escitalopram
Generic Name: escitalopram
NDC Code (Product): 52427-795
Manufacturer: Almatica Pharma LLC
Strength: 15 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA219130
Marketing Start: 10/06/2025

Recall History

2 Recalls on Record

Class III03/24/2016

Lupin Limited

Labeling: Incorrect or Missing Lot and/or Expiration Date

TerminatedVoluntary: Firm initiated

Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003707, EXP: 6/25/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,666 reports

fatigue4,475 reports

nausea4,245 reports

off label use3,743 reports

headache3,624 reports

diarrhoea3,593 reports

drug interaction3,035 reports

dizziness3,016 reports

fall2,975 reports

anxiety2,900 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Escitalopram 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. Escitalopram 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 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Indication and Population Recommended Dosage MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily No additional benefits were seen at 20 mg once daily ( 2.1 ) Administer once daily, morning or evening, with or without food ( 2.3 ) Elderly patients: recommended dosage is 10 mg once daily ( 2.4 ) Hepatic impairment: recommended dosage is 10 mg once daily ( 2.4 , 8.6 ) When discontinuing escitalopram, reduce dose gradually whenever possible ( 2.5 ) 2.1 Major Depressive Disorder Adults The recommended dosage of escitalopram in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [ see Clinical Studies (14.1) ]. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once …

Contraindications

4 CONTRAINDICATIONS Escitalopram is contraindicated in patients: taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use of escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration (2.7) and Warnings and Precautions (5.2) ]. Starting escitalopram in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [ see Dosage and Administration (2.6) and Warnings and Precautions (5.2) ]. taking pimozide [ see Drug Interactions (7) ] with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in escitalopram. Do not use MAOIs intended to treat psychiatric disorders with escitalopram or within 14 days of stopping treatment with escitalopram. Do not use escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram in a patient who is being treated with linezolid or intravenous methylene blue ( 4 ) Concomitant use of …

Drug Interactions

7 DRUG INTERACTIONS Table 6 presents clinically important drug interactions with escitalopram. TABLE 6 Clinically Important Drug Interactions with Escitalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including escitalopram, and MAOIs increases the risk of serotonin syndrome. Intervention: Escitalopram is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [ see Dosage and Administration (2.7) , Contraindications (4) , and Warnings and Precautions (5.2) ] Pimozide Clinical Impact: Concomitant use of racemic citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of racemic citalopram alone [ see Clinical Pharmacology (12.3) ]. Intervention: Escitalopram is contraindicated in patients taking pimozide [ see Contraindications (4) ]. Other Serotonergic Drugs Clinical Impact: Concomitant use of escitalopram and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptop…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [ see Warnings and Precautions (5.1) ] Serotonin syndrome [ see Warnings and Precautions(5.2) ] Discontinuation syndrome [ see Warnings and Precautions(5.3) ] Seizures [ see Warnings and Precautions (5.4) ] Activation of mania or hypomania [ see Warnings and Precautions (5.5) ] Hyponatremia [ see Warnings and Precautions (5.6) ] Increased Risk of Bleeding [ see Warnings and Precautions (5.7) ] Interference with Cognitive and Motor Performance [ see Warnings and Precautions (5.8) ] Angle-closure glaucoma [ see Warnings and Precautions (5.9) ] Use in Patients with Concomitant Illness [ see Warnings and Precautions (5.10) ] Sexual Dysfunction [ see Warnings and Precautions (5.11) ] Most commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell R…

Frequently Asked Questions

What is escitalopram used for?

escitalopram contains escitalopram. It is a capsule taken oral. Consult your doctor for specific uses.

Is escitalopram a controlled substance?

escitalopram is not classified as a controlled substance by the DEA.

What is the generic name for escitalopram?

The generic name for escitalopram is escitalopram. There are 10 other brand versions of escitalopram.

What is the NDC code for escitalopram 15 mg/1?

The NDC (National Drug Code) for escitalopram 15 mg/1 is 52427-795, listed by Almatica Pharma LLC.

Product NDC

52427-795

Package NDC

52427-795-30

Other escitalopram Dosages

Other Escitalopram Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)