Sertraline Hydrochloride
NDC Package 10135-694-61

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 inactivated by the FDA.

Sertraline Hydrochloride is the use of MAOIs intended to treat psychiatric disorders with Sertraline Hydrochloride Oral Concentrate or within 14 days of stopping treatment with Sertraline Hydrochloride Oral Concentrate is contraindicated because of an increased risk of serotonin syndrome. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-694 and is authorized under FDA application ANDA076934.

Identification & Billing

NDC Package Code
10135-694-61
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 mL in 1 BOTTLE, PLASTIC
Product Code
10135-694
11-Digit Billing Format
10135069461
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 861064 - sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 861064 - sertraline 20 MG/ML Oral Solution
  • RxCUI: 861064 - sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution

Clinical Specifications

Proprietary Name
Sertraline Hydrochloride
Dosage Form
-
Usage Information
The use of MAOIs intended to treat psychiatric disorders with Sertraline Hydrochloride Oral Concentrate or within 14 days of stopping treatment with Sertraline Hydrochloride Oral Concentrate is contraindicated because of an increased risk of serotonin syndrome. The use of Sertraline Hydrochloride Oral Concentrate within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting Sertraline Hydrochloride Oral Concentrate 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 WARNINGS and DOSAGE AND ADMINISTRATION). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Sertraline Hydrochloride Oral Concentrate is contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in Sertraline Hydrochloride Oral Concentrate.Sertraline Hydrochloride Oral Concentrate is contraindicated with ANTABUSE (disulfiram) due to the alcohol content of the concentrate.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals Inc
FDA Application #
ANDA076934
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2020
Listing Expiration
12-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-694-61 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 ml in 1 bottle, plastic of Sertraline Hydrochloride, labeled by Marlex Pharmaceuticals Inc. 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 Marlex Pharmaceuticals Inc on March 01, 2020. The current certification is valid through December 31, 2021.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135069461. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
10135-694-61
11-Digit CMS (5-4-2)
10135-0694-61

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