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  5. NDC Package Code: 10135-694-61 Sertraline Hydrochloride

NDC Package 10135-694-61 Sertraline Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
10135-694-61
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 60 mL in 1 BOTTLE, PLASTIC
Product Code:
10135-694
Proprietary Name:
Sertraline Hydrochloride
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.
11-Digit NDC Billing Format:
10135069461
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Labeler Name:
    Marlex Pharmaceuticals Inc
    Sample Package:
    No
    Start Marketing Date:
    03-01-2020
    Listing Expiration Date:
    12-31-2021
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 10135-694-61?

    The NDC Packaged Code 10135-694-61 is assigned to a package of 1 bottle, plastic in 1 carton / 60 ml in 1 bottle, plastic of Sertraline Hydrochloride, labeled by Marlex Pharmaceuticals Inc. The product's dosage form is and is administered via form.

    Is NDC 10135-694 included in the NDC Directory?

    No, Sertraline Hydrochloride with product code 10135-694 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Marlex Pharmaceuticals Inc on March 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 10135-694-61?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 10135-694-61?

    The 11-digit format is 10135069461. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-210135-694-615-4-210135-0694-61