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Escitalopram Oxalate 20 mg Tablet, Film Coated, 1,000-count

by Amneal Pharmaceuticals LLC · 1000 TABLET, FILM COATED in 1 BOTTLE (65162-021-11)

NDC 65162-0021-11

🏷️ FDA NDC (as labeled) 65162-021-11 billing pads the product segment with a zero

This package

Contains1,000-count Pack sizes4 compare ↓

Also priced by: Part D plans $0.1381/unit — full pricing hub ↓

Also comes in: 30 tablets 65162-0021-03 90 tablets 65162-0021-09 500 tablets 65162-0021-50

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 65162-021-11

Product NDC 65162-021

11-digit billing NDC 65162002111

RxCUI 349332, 351249, 351250

UNII 5U85DBW7LO

UPC 0365162021035, 0365162020038

Application # ANDA205619

SPL Set ID 8704d062-fa91-4224-9dec-41664d20ee6b

Established class (EPC) Serotonin Reuptake Inhibitor

Mechanism of action Serotonin Uptake Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2017-05-17

Route ORAL

Dosage form TABLET, FILM COATED

Substance ESCITALOPRAM OXALATE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 65162-021-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65162-0021-11. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor

Drug family (ATC) Selective serotonin reuptake inhibitors

How it works Serotonin Uptake Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC

Application holderAMNEAL PHARMACEUTICALS

FDA applicationANDA205619 (ANDA)

Labeler code65162

First marketedMay 2017

Product typeHuman Prescription Drug

Portfolio467 products on file

🔎 All NDCs from Amneal Pharmaceuticals LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

That's one of the most common questions — and honestly, antidepressants do take time. Most people don't notice a full effect in the first week or two. It often takes several weeks...
How long will it take before I start feeling better on escitalopram?
It's great that you're feeling better — but please don't stop on your own. Stopping escitalopram abruptly can cause withdrawal-like symptoms like dizziness, irritability, and a flu...
Can I stop taking escitalopram once I feel better?

📖 Read our full Escitalopram guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Escitalopram may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

SODIUM Moderate Depletion

🧪 Full Escitalopram nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.1381	$138.10 / 1000 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
escitalopram 20 mg 00904-6427-61	Major	100 tablets	$0.063	AB	Availability likely	—
escitalopram 20 mg 13668-0137-01	Torrent	100 tablets	$0.063	AB	Availability likely	—
escitalopram 20 mg 16571-0757-01	Rising	100 tablets	$0.063	AB	Availability likely	—
Escitalopram 20 mg 43547-0282-10	SOLCO	100 tablets	$0.063	AB	Availability likely	—
Escitalopram 20 mg 65862-0375-01	Aurobindo	100 tablets	$0.063	AB	Availability likely	—
Escitalopram 20 mg 68001-0593-00	BluePoint	100 tablets	$0.063	AB	Availability likely	—
Escitalopram 20 mg 68084-0618-01	American	1 tablet	$0.063	AB	Availability likely	—
Escitalopram Oxalate 20 mg 68645-0520-54	Legacy	30 tablets	$0.063	AB	Availability likely	—
Escitalopram Oxalate 20 mg/21 72603-0151-01	NorthStar	1000 tablets	$0.063	AB	Availability likely	—
escitalopram oxalate 20 mg 82009-0037-10	Quallent	1000 tablets	$0.063	AB	Availability likely	—
Escitalopram 20 mg 59746-0281-01	Jubilant	100 tablets	$0.076	AB	FDA listed	—
Escitalopram 20 mg 16729-0170-01	Accord	100 tablets	$0.086	AB	FDA listed	—
Escitalopram Oxalate 20 mg/21 33342-0038-11	Macleods	100 tablets	$0.086	AB	FDA listed	—
Lexapro 20 mg 00456-2020-01	Allergan,	100 tablets	$16.124	AB	Availability likely	—
Escitalopram 20 mg 00615-8477-05	NCS	15 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 42708-0163-30	QPharma,	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 43063-0661-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Escitalopram Oxalate 20 mg 43602-0475-10	Ascent	1000 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 50090-6023-00	A-S	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 50090-6534-00	A-S	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 50090-6897-00	A-S	90 tablets	—	AB	FDA listed	—
Escitalopram Oxalate 20 mg/21 50090-7200-00	A-S	30 tablets	—	AB	FDA listed	—
Escitalopram Oxalate 20 mg/21 50090-7201-00	A-S	90 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 51655-0147-26	Northwind	90 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 51655-0236-52	Northwind	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 51655-0284-26	Northwind	90 tablets	—	AB	FDA listed	—
Escitalopram Oxalate 20 mg 53746-0021-05	Amneal	500 tablets	—	AB	FDA listed	—
escitalopram 20 mg 55154-7288-00	Cardinal	10 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 55700-0818-30	Quality	30 tablets	—	AB	Discontinued	—
Escitalopram 20 mg 60760-0590-90	St.	90 tablets	—	AB	FDA listed	—
Escitalopram Oxalate 20 mgthis 65162-0021-11	Amneal	1000 tablets	—	AB	FDA listed	—
escitalopram 20 mg 67046-1465-03	Coupler	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 67296-1421-03	RedPharm	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 68071-3069-03	NuCare	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 68071-4985-03	NuCare	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 68071-5248-09	NuCare	90 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 68788-7461-01	Preferred	100 tablets	—	AB	FDA listed	—
escitalopram 20 mg 68788-8723-01	Preferred	100 tablets	—	AB	FDA listed	—
Escitalopram Oxalate 20 mg 69097-0849-02	Cipla	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 70518-2317-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
escitalopram 20 mg 70518-4239-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 71205-0193-30	Proficient	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 71205-0325-30	Proficient	30 tablets	—	AB	FDA listed	—
escitalopram oxalate 20 mg 71335-0685-01	Bryant	60 tablets	—	AB	Discontinued	—
Escitalopram 20 mg 71335-1002-01	Bryant	60 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 71335-1307-01	Bryant	60 tablets	—	AB	Discontinued	—
escitalopram 20 mg 71335-2331-01	Bryant	60 tablets	—	AB	FDA listed	—
escitalopram 20 mg 71335-2960-01	Bryant	1000 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 71610-0425-60	Aphena	90 tablets	—	AB	FDA listed	—
Escitalopram oxalate 20 mg 71610-0534-60	Aphena	90 tablets	—	AB	FDA listed	—
escitalopram 20 mg 72162-2240-00	Bryant	1000 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 72189-0438-30	Direct_Rx	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 72189-0451-30	Direct_Rx	30 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 72789-0311-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Escitalopram oxalate 20 mg 76282-0251-01	Exelan	100 tablets	—	AB	FDA listed	—
Escitalopram 20 mg 76420-0723-01	Asclemed	100 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2017

On the market since

May 2017

📍

2026

Currently FDA-listed

9 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Escitalopram Oxalate — the program that covers self-administered drugs. 17 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Escitalopram Oxalate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$51.99M

Claims incl. refills

3.2M

Beneficiaries

Spend / beneficiary

$25.41

Spend / claim

$16.12

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Escitalopram Oxalate — the ingredient across all brands.

Top reported reactions

Fatigue4,606

Nausea4,373

Headache3,747

Diarrhoea3,735

Drug Interaction3,118

Dizziness3,098

Fall3,060

Age at onset

Neonate263

Infant54

Child42

Adolescent381

Adult7,778

Elderly5,051

Reporter sex

Male · 34%

Female · 66%

Unknown · 0%

Serious outcomes

Hospitalization26,973

Life-threatening4,711

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
65162-0021-03	30 TABLET, FILM COATED in 1 BOTTLE (65162-021-03)	2017-05-17	Active
65162-0021-09	90 TABLET, FILM COATED in 1 BOTTLE (65162-021-09)	2017-05-17	Active
65162-0021-11 You're viewing this	1000 TABLET, FILM COATED in 1 BOTTLE (65162-021-11)	2017-05-17	Active
65162-0021-50	500 TABLET, FILM COATED in 1 BOTTLE (65162-021-50)	2017-05-17	Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65162-0021-11?

NDC 65162-0021-11 is a 1,000-count package — 1000 tablet, film coated in 1 bottle.

What is the difference between NDC 65162-0021-11 and NDC 65162-0021-03?

Both are Escitalopram Oxalate 20 mg Tablet, Film Coated — the drug itself is identical. NDC 65162-0021-11 is the 1,000-count package, while NDC 65162-0021-03 is the 30 tablets package.

What NDC number is used to bill for this package of Escitalopram Oxalate 20 mg Tablet, Film Coated?

Bill NDC 65162-0021-11 — the 11-digit billing format is 65162002111. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 65162-021-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65162-0021-11, written without dashes as 65162002111. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 65162-0021-11, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (65162-0021-03), 90 tablets (65162-0021-09), 500 tablets (65162-0021-50). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 131 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Escitalopram is not approved for use in pediatric patients less than 7 years of age [see Use in Specific Populations (8.4) ].

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).

Escitalopram is not approved for use in pediatric patients less than 7 years of age ( 8.4 ).

🎯 Indications and Usage 101 words ▾

1 INDICATIONS AND USAGE Escitalopram tablets are 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. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Escitalopram tablets are 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 and Administration ~3 min read ▾

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 tablets, reduce dose gradually whenever possible.

( 2.5 )

2.1Major Depressive Disorder Adults The recommended dosage of escitalopram tablets in adults is 10 mg once daily. A fixed-dose trial of escitalopram tablets demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets, 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 daily at an interval of no less than 1 week.

Pediatric Patients 12 years of age and older The recommended dosage of escitalopram tablets in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks.

2.2Generalized Anxiety Disorder Adults The recommended starting dosage of escitalopram tablets in adults is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets.

However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.3Administration Information Administer escitalopram tablets orally once daily, in the morning or evening, with or without food.

2.4Screen for Bipolar Disorder Prior to Starting Escitalopram Tablets Prior to initiating treatment with escitalopram tablets or another antidepressant, screen patients for a personal family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.5) ] .

2.5Recommended Dosage for Specific Populations The recommended dosage for most elderly patients and patients with hepatic impairment is 10 mg once daily [see Use in Specific Populations (8.5, 8.6) ] . The recommended dosage for escitalopram tablets in adults with a creatinine clearance less than 20 mL/minute has not been determined. No dosage adjustment is necessary for patients with mild or moderate renal impairment [see Use in Specific Populations (8.7) ] .

2.6Discontinuation of Treatment with Escitalopram Tablets Symptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3) ] . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

2.7Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be allowed after stopping escitalopram tablets before starting an MAOI intended to treat…

💊 Dosage Forms and Strengths 108 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg (scored) and 20 mg (scored). Escitalopram tablets USP, 5 mg are white to off-white, round shaped, non-scored, film-coated tablets, debossed with “AN 019” on one side and plain on the other side. Escitalopram tablets USP, 10 mg are white to off-white, round shaped, scored, film-coated tablets, debossed with “AN” on above bisect and “020” below bisect on one side and plain on the other side.

Escitalopram tablets USP, 20 mg are white to off-white, round shaped, scored, film-coated tablets, debossed with “AN” on above bisect and “021” below bisect on one side and plain on the other side.

⛔ Contraindications 205 words ▾

4 CONTRAINDICATIONS Escitalopram tablets are 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 tablets.

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 pimozide. ( 4 ) Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue escitalopram and serotonergic agents and initiate supportive treatment. ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing escitalopram, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms.

( 5.3 ) Seizures: Use with caution in patients with a history of seizure. ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder. ( 5.5 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion.

( 5.6 ) Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk. ( 5.7 ) Interference with Cognitive and Motor Performance: Use caution when operating machinery. ( 5.8 ) Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.

( 5.9 ) Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. ( 5.10 ) Sexual Dysfunction: Escitalopram may cause symptoms of sexual dysfunction. ( 5.11 )

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1 . Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts and Behaviors per 1,000 Patients Treated Increases Compared to Placebo < 18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥ 65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e. beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing escitalopram, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome SSRIs, including escitalopram, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tram…

🤒 Adverse Reactions ~3 min read ▾

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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Clinical Trial Data Sources Adults Adverse reactions information for escitalopram was collected from 715 patients with major depressive disorder who were exposed to escitalopram and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials.

An additional 284 patients with major depressive disorder were newly exposed to escitalopram in open-label trials. The adverse reaction information for escitalopram in patients with GAD was collected from 429 patients exposed to escitalopram and from 427 patients exposed to placebo in double-blind, placebo-controlled trials. Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing.

Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse reactions. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment emergent adverse event of the type listed.

An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Pediatric Patients Adverse reaction information for pediatric patients was collected in double-blind placebo-controlled studies in 576 pediatric patients 6 to 17 years of age, (286 escitalopram, 290 placebo) with major depressive disorder. The safety and effectiveness of escitalopram have not been established in pediatric patients less than 12 years of age with MDD or less than 7 years of age with GAD.

Adverse Reactions Associated with Discontinuation of Treatment Major Depressive Disorder Adults Among the 715 depressed patients who received escitalopram in placebo-controlled trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed-dose studies, the rate of discontinuation for adverse reactions in patients receiving 10 mg/day escitalopram was not significantly different from the rate of discontinuation for adverse reactions in patients receiving placebo.

The rate of discontinuation for adver…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 6 presents clinically important drug interactions with escitalopram. TABLE 6: Clinically Important Drug Interactions with E scitalopram 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, tryptophan, and St.

John's Wort) increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during escitalopram initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of escitalopram and/or concomitant serotonergic drugs [see Warning and Precautions (5.2) ] .

Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) Clinical Impact: Concomitant use of escitalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of escitalopram and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions (5.7) ] .

Sumatriptan Clinical Impact: There have been post-marketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of an SSRI and sumatriptan. Intervention: If concomitant treatment with sumatriptan and an SSRI is clinically warranted, appropriate observation of the patient is advised [see Warning and Precautions (5.2) ] . Carbamazepine Clinical Impact: Combined administration of racemic citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate.

Intervention: Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of escitalopram should be considered if the two drugs are co-administered. Drugs Metabolized by CYP2D6 Clinical Impact: Co-administration of escitalopram (20 mg/day for 21 days) with the tricyclic antidepressant desipramine (single-dose of 50 mg), a substrate for CYP2D6, resulted in a 40% increase in C max and a 100% increase in AUC of desipramine.

Intervention: The clinical significance of this finding is unknown. Exercise caution during co-administration of escitalopram and drugs metabolized by CYP2D6. Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended.

(7) Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin). (7)

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. ( 8.1 ) Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7 ) and Clinical Considerations] .

Available data from published epidemiologic studies and post-marketing reports have not established an increased risk of major birth defects or miscarriage. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation (see Clinical Considerations) with exposure to selective serotonin reuptake inhibitors (SSRIs), including escitalopram, during pregnancy. There are risks associated with untreated depression in pregnancy (see Clinical Considerations).

In animal reproduction studies, both escitalopram and racemic citalopram have been shown to have adverse effects on embryo/fetal and postnatal development, including fetal structural abnormalities, when administered at doses greater than human therapeutic doses (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal risk and/or embryo/fetal risk Women who discontinue antidepressants are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of major depression, who were euthymic and taking antidepressants at the beginning of pregnancy.

Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of escitalopram in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7) ] . Fetal/Neonatal adverse reactions Neonates exposed to SSRIs or SNRIs, including escitalopram, late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.

🤰 Pregnancy ~2 min read ▾

It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2) ] . Data Human Data Exposure to SSRIs, particularly later in pregnancy, may increase the risk for PPHN. PPHN occurs in 1 to 2 per 1,000 live births in the general populations and is associated with substantial neonatal morbidity and mortality.

Animal Data In a rat embryo/fetal development study, oral administration of escitalopram (56, 112, or 150 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased fetal body weight and associated delays in ossification at the two higher doses [approximately ≥ 55 times the maximum recommended human dose (MRHD) of 20 mg/day on…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Major Depressive Disorder The safety and effectiveness of escitalopram for the treatment of major depressive disorder have been established in pediatric patients 12 years of age and older. Use of escitalopram for this indication is supported by evidence from adequate and well-controlled studies in adults with additional evidence from an 8-week, flexible-dose, placebo-controlled study that compared escitalopram 10 mg to 20 mg once daily to placebo in pediatric patients 12 to 17 years of age with major depressive disorder [see Clinical Studies (14.1) ] .

The safety of escitalopram was similar to adult patients with MDD [see A dverse Reactions (6.1) ] . The safety and effectiveness of escitalopram for the treatment of major depressive disorder have not been established in pediatric patients younger than 12 years of age. In a 24-week, open-label safety study in 118 pediatric patients aged 7 to 11 years who had major depressive disorder, the safety findings were consistent with the known safety and tolerability profile for escitalopram.

Generalized Anxiety Disorder The safety and effectiveness of escitalopram for the treatment of generalized anxiety disorder have not been established in pediatric patients younger than 7 years of age. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings and Precautions (5.1) ] . Decreased appetite and weight loss have been observed in association with the use of SSRIs.

Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as escitalopram. Juvenile Animal Toxicity Data In a juvenile animal study, male and female rats were administered escitalopram at 5, 40, or 80 mg/kg/day by oral gavage from postnatal day (PND) 21 to PND 69. A delay in sexual maturation was observed in both males and females at ≥ 40 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 5 mg/kg/day.

This NOAEL was associated with plasma AUC levels less than those measured at the maximum recommended dose (MRHD) in pediatrics (20 mg). However, there was no effect on reproductive function. Increased motor activity (both ambulatory and fine movements) was observed in females prior to daily dosing at ≥ 40 mg/kg/day (3.5 times the MRHD based on AUC levels).

A reversible disruption of learning and memory function was observed in males at 80 mg/kg/day with a NOAEL of 40 mg/kg/day, which was associated with an AUC level 3.5 times those measured at the MRHD in pediatrics. There was no effect on learning and memory function in treated female rats. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets.

However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Approximately 69 patients (6%) of the 1,144 patients receiving escitalopram in controlled trials of escitalopram in major depressive disorder and GAD were 60 years of age or older [see Clinical Studies (14.1 , 14.2) ] . The number of elderly patients in these trials was insufficient to adequately assess for possible differential efficacy and safety measures on the basis of age. Nevertheless, greater sensitivity of some elderly individuals to effects of escitalopram cannot be ruled out.

In two pharmacokinetic studies, escitalopram half-life was increased by approximately 50% in subjects 65 years and older as compared to young subjects and C max was unchanged [see Clinical Pharmacology (12.3) ] . The recommended dosage of escitalopram for elderly patients is 10 mg daily [see Dosage and Administration (2.5) ] . SSRIs, including escitalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.6) ] .

Of 4,422 patients in clinical studies of racemic citalopram, 1,357 were 60 and over, 1,034 were 65 and over, and 457 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the geriatric and younger patients, but again, greater sensitivity of some elderly individuals cannot be ruled out.

🆘 Overdosage 120 words ▾

10 OVERDOSAGE The following have been reported with escitalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.

Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in escitalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a escitalopram overdose.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).

12.2Pharmacodynamics In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal reuptake. Escitalopram is at least 100-fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of 5-HT neuronal firing rate. Tolerance to a model of antidepressant effect in rats was not induced by long-term (up to 5 weeks) treatment with escitalopram.

Escitalopram has no or very low affinity for serotonergic (5-HT 1-7 ) or other receptors including alpha- and beta-adrenergic, dopamine (D 1-5 ), histamine (H 1-3 ), muscarinic (M 1-5 ), and benzodiazepine receptors. Escitalopram also does not bind to, or has low affinity for, various ion channels including Na + , K + , Cl - , and Ca ++ channels. Antagonism of muscarinic, histaminergic, and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular side effects of other psychotropic drugs.

12.3Pharmacokinetics The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10 mg/day to 30 mg/day. With once-daily dosing, steady-state plasma concentrations are achieved within approximately one week. At steady-state, the extent of accumulation of escitalopram in plasma in young healthy subjects was 2.2 to 2.5 times the plasma concentrations observed after a single-dose.

Absorption The absolute bioavailability of citalopram is about 80% relative to an intravenous dose. The tablet and the oral solution dosage forms of escitalopram oxalate are bioequivalent. Following a single oral dose (20 mg) of escitalopram, peak blood levels occur at about 5 hours.

Absorption of escitalopram is not affected by food. Distribution The binding of escitalopram to human plasma proteins is approximately 56%. The volume of distribution of citalopram is about 12 L/kg.

Data specific on escitalopram are unavailable. Elimination Biotransformation of escitalopram is mainly hepatic, with a mean terminal half-life of about 27 to 32 hours. The oral clearance of escitalopram is 600 mL/min, with approximately 7% of that due to renal clearance.

Metabolism Escitalopram is metabolized to S-DCT and S-didesmethylcitalopram (S-DDCT). In humans, unchanged escitalopram is the predominant compound in plasma. At steady-state, the concentration of the escitalopram metabolite S-DCT in plasma is approximately one-third that of escitalopram.

The level of S-DDCT was not detectable in most subjects. In vitro studies show that escitalopram is at least 7 and 27 times more potent than S-DCT and S-DDCT, respectively, in the inhibition of serotonin reuptake, suggesting that the metabolites of escitalopram do not contribute significantly to the antidepressant actions of escitalopram. S-DCT and S-DDCT also have no or very low affinity for serotonergic (5-HT 1-7) or other receptors including alpha- and beta-adrenergic, dopamine (D 1-5 ), histamine (H 1-3 ), muscarinic (M 1-5 ), and benzodiazepine receptors.

S-DCT and S-DDCT also do not bind to various ion channels including Na + , K + , Cl - , and Ca ++ channels. In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary isozymes involved in the N-demethylation of escitalopram. Excretion Following oral administrations of escitalopram, the fraction of drug recovered in the urine as escitalopram and S-demethylcitalopram (S-DCT) is about 8% and 10%, respectively.

Specific Populations Pediatric Patients Pediatric patients 12 to 17 years of age: In a single-dose study of 10 mg escital…

🧬 Mechanism of Action 43 words ▾

📦 How Supplied / Storage and Handling 206 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Escitalopram tablets USP, 5 mg are supplied as white to off-white, round shaped, non-scored, film-coated tablets, debossed with “AN 019” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-019-03 Bottles of 90: NDC 65162-019-09 Bottles of 500: NDC 65162-019-50 Bottles of 1000: NDC 65162-019-11 Escitalopram tablets USP, 10 mg are supplied as white to off-white, round shaped, scored, film-coated tablets, debossed with “AN” on above bisect and “020” below bisect on one side and plain on the other side.

They are available as follows: Bottles of 30: NDC 65162-020-03 Bottles of 90: NDC 65162-020-09 Bottles of 500: NDC 65162-020-50 Bottles of 1000: NDC 65162-020-11 Escitalopram tablets USP, 20 mg are supplied as white to off-white, round shaped, scored, film-coated tablets, debossed with “AN” on above bisect and “021” below bisect on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-021-03 Bottles of 90: NDC 65162-021-09 Bottles of 500: NDC 65162-021-50 Bottles of 1000: NDC 65162-021-11 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 185 words ▾

11 DESCRIPTION Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p -fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula: The molecular formula is C 20 H 21 FN 2 O • C 2 H 2 O 4 and the molecular weight is 414.40.

Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored.

The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP. hj

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients, their families and caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [ see Boxed Warning and Warnings and Precautions (5.1) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of escitalopram with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St.

John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) , Drug Interactions (7) ]. Discontinuation Syndrome Advise patients not to abruptly discontinue escitalopram tablets and to discuss any tapering regimen with their healthcare provider.

Inform patients that adverse reactions can occur when escitalopram tablets discontinued [see Warnings and Precautions (5.3) ] . Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.5) ] . Increased Risk of Bleeding Inform patients about the concomitant use of escitalopram with NSAIDs, aspirin, warfarin, other antiplatelet drugs, or other anticoagulants because the combined use has been associated with an increased risk of bleeding.

Advise patients to inform their healthcare providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.7) ] . Angle Closure Glaucoma Advise patients that taking escitalopram can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy.

Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.9) ] . Sexual Dysfunction Advise patients that use of escitalopram may cause symptoms of sexual dysfunction in both male and female patients.

Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11) ] . Concomitant Medications Since escitalopram is the active isomer of racemic citalopram (Celexa), the two agents should not be co-administered. Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions.

Interference with Psychomotor Performance Because psychoactive drugs may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that escitalopram therapy does not affect their ability to engage in such activities. Alcohol Patients should be told that, although escitalopram has not been shown in experiments with normal subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of escitalopram and alcohol in depressed patients is not advised.

Pregnancy Advise pregnant women to notify their healthcare provi…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Escitalopram (es” sye tal’ oh pram) Tablets, USP What is the most important information I should know about escitalopram tablets? Escitalopram tablets may cause serious side effects, including: Increased risk of suicidal thoughts or actions. Escitalopram tablets and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develop suicidal thoughts or actions.

This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you or your child develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled and call your healthcare provider between visits if you are worried about symptoms.

Call your healthcare provider or get emergency medical help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive, being angry or violent new or worse depression panic attacks new or worse irritability an extreme increase in activity or talking (mania) acting on dangerous impulses thoughts about suicide or dying new or worsening anxiety feeling very agitated or restless trouble sleeping other unusual changes in behavior or mood What are escitalopram tablets?

Escitalopram tablets are a prescription medicine used to treat: a certain type of depression called Major Depressive Disorder (MDD) in adults and children 12 years of age and older Generalized Anxiety Disorder (GAD) in adults It is not known if escitalopram tablets are safe and effective for use in children under 12 years of age with MDD or children under 7 years of age with GAD. Do not take escitalopram tablets if you or your child: are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue are taking the antipsychotic medicine pimozide are allergic to escitalopram or citalopram or any of the ingredients in escitalopram tablets.

See the end of this Medication Guide for a complete list of ingredients in escitalopram tablets. Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with escitalopram tablets .

Before taking escitalopram tablets, tell your healthcare provider about all your medical conditions, including if you or your child: have or had seizures or convulsions have, or have a family history of bipolar disorder, mania, or hypomania have low blood sodium levels have or had bleeding problems have high pressure in the eye (glaucoma) have heart, liver, or kidney problems are pregnant or plan to become pregnant. Escitalopram tablets may harm the unborn baby. Taking escitalopram tablets during the third trimester of pregnancy may cause the baby to have withdrawal symptoms, or breathing, temperature control, feeding, or other problems after birth.

Talk to your healthcare provider about the risks to the baby if you or your child take escitalopram tablets during pregnancy. Tell your healthcare provider right away if you or your child become pregnant or think you may be pregnant during treatment with escitalopram tablets. There is a pregnancy registry for females who are exposed to escitalopram tablets during pregnancy.

The…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

sedative: A substance with a calming effect that can also cause drowsiness.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

narrow therapeutic index: Describes a medicine where the helpful dose and the harmful dose are very close, so small changes in the amount matter a lot.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pulmonary hypertension: High blood pressure in the arteries that carry blood from the heart to the lungs.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

relapse: The return of a cancer after a period of improvement or disappearance.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

therapeutic index: A measure of how much room there is between a helpful dose of a medicine and a dose that could be harmful.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 65162-0020-03 · Amneal 65162-0023-09 · Amneal →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Escitalopram Oxalate 20 mg Tablet, Film Coated, 1,000-count

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