Escitalopram Oxalate
NDC Package 69315-501-24

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Escitalopram Oxalate is escitalopram is used to treat depression and anxiety. Marketed by Leading Pharma, Llc, this product is identified by NDC 69315-501 and is authorized under FDA application ANDA203967.

Identification & Billing

NDC Package Code
69315-501-24
Package Description
1 BOTTLE in 1 BOTTLE / 240 mL in 1 BOTTLE
Product Code
69315-501
11-Digit Billing Format
69315050124

Clinical Specifications

Proprietary Name
Escitalopram Oxalate
Dosage Form
-
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
Leading Pharma, Llc
FDA Application #
ANDA203967
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2015
End Marketing Date
08-16-2018
Listing Expiration
08-16-2018
Exclude Flag
D
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 69315-501-24 identifies a specific commercial package of 1 bottle in 1 bottle / 240 ml in 1 bottle of Escitalopram Oxalate, labeled by Leading Pharma, Llc. 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 Leading Pharma, Llc on August 01, 2015. The current certification is valid through August 16, 2018.

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 Leading Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69315050124. 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)
69315-501-24
11-Digit CMS (5-4-2)
69315-0501-24

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