Escitalopram Solution
NDC Package 33342-053-28

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

Package Information

Escitalopram solution is escitalopram is used to treat depression and anxiety. This formulation utilizes a solution delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-053 and is authorized under FDA application ANDA202754.

Identification & Billing

NDC Package Code
33342-053-28
Package Description
240 mL in 1 BOTTLE
Product Code
33342-053
11-Digit Billing Format
33342005328
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk
  • RxCUI: 351285 - escitalopram 5 MG in 5 mL Oral Solution
  • RxCUI: 351285 - escitalopram 1 MG/ML Oral Solution
  • RxCUI: 351285 - escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral Solution
  • RxCUI: 351285 - escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Escitalopram
Non-Proprietary Name
Escitalopram
Substance Name
Escitalopram Oxalate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ESCITALOPRAM OXALATE 5 mg/5mL
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202754
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 33342-053-28 identifies a specific commercial package of 240 ml in 1 bottle of Escitalopram, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This solution 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 Macleods Pharmaceuticals Limited on March 31, 2016. 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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342005328. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 total billable units per package. 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)
33342-053-28
11-Digit CMS (5-4-2)
33342-0053-28

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