Escitalopram Oxalate Tablet, Film Coated
NDC Package 53746-021-05

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

Escitalopram Oxalate tablets is escitalopram is used to treat depression and anxiety. This formulation utilizes a tablet, film coated delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 53746-021 and is authorized under FDA application ANDA205619.

Identification & Billing

NDC Package Code
53746-021-05
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
53746-021
11-Digit Billing Format
53746002105
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Escitalopram Oxalate
Non-Proprietary Name
Escitalopram Oxalate
Substance Name
Escitalopram Oxalate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ESCITALOPRAM OXALATE 20 mg/1
Pharmacologic Class
Usage Information
Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI). It may improve your energy level and feelings of well-being and decrease nervousness.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA205619
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 (53746-021). Click a package code to view its specific billing and regulatory data.

53746-021-10
1000 TABLET, FILM COATED in 1 BOTTLE
53746-021-30
30 TABLET, FILM COATED in 1 BOTTLE
53746-021-90
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 53746-021-05 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Escitalopram Oxalate, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This tablet, film coated is formulated for oral use and contains escitalopram oxalate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Of New York Llc on May 17, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI). It may improve your energy level and feelings of well-being and decrease nervousness.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53746002105. 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)
53746-021-05
11-Digit CMS (5-4-2)
53746-0021-05

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