Escitalopram
NDC Package 61919-652-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Escitalopram is 1.1 Major Depressive DisorderEscitalopram tablet USP is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1) ].A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.1.2 Generalized Anxiety DisorderEscitalopram tablet USP is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies ( 14.2) ].Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. Marketed by Directrx, this product is identified by NDC 61919-652 and is authorized under FDA application ANDA202389.

Identification & Billing

NDC Package Code
61919-652-20
Package Description
20 TABLET, FILM COATED in 1 BOTTLE
Product Code
61919-652
11-Digit Billing Format
61919065220
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Escitalopram
Dosage Form
-
Usage Information
1.1 Major Depressive DisorderEscitalopram tablet USP is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1) ].A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.1.2 Generalized Anxiety DisorderEscitalopram tablet USP is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies ( 14.2) ].Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

Regulatory & Marketing

Labeler Name
Directrx
FDA Application #
ANDA202389
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2015
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61919-652). Click a package code to view its specific billing and regulatory data.

61919-652-30
30 TABLET, FILM COATED in 1 BOTTLE
61919-652-60
60 TABLET, FILM COATED in 1 BOTTLE
61919-652-90
90 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61919-652-20 identifies a specific commercial package of 20 tablet, film coated in 1 bottle of Escitalopram, labeled by Directrx. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Directrx on January 01, 2015. The current certification is valid through December 31, 2024.

How is this Directrx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919065220. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61919-652-20
11-Digit CMS (5-4-2)
61919-0652-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.