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  5. NDC Package Code: 65862-224-20 Sertraline Hydrochloride

NDC Package 65862-224-20 Sertraline Hydrochloride

Solution, Concentrate Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
65862-224-20
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 60 mL in 1 BOTTLE, PLASTIC
Product Code:
65862-224
Proprietary Name:
Sertraline Hydrochloride
Non-Proprietary Name:
Sertraline Hydrochloride
Substance Name:
Sertraline Hydrochloride
Usage Information:
Sertraline hydrochloride oral solution is indicated for the treatment of the following [See Clinical Studies (14)]:Major depressive disorder (MDD)Obsessive-compulsive disorder (OCD)Panic disorder (PD)Posttraumatic stress disorder (PTSD)Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD)
11-Digit NDC Billing Format:
65862022420
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SERTRALINE HYDROCHLORIDE 20 mg/mL
    • Pharmacologic Class(es):
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078861
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-31-2008
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65862-224-601 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-224-20?

    The NDC Packaged Code 65862-224-20 is assigned to a package of 1 bottle, plastic in 1 carton / 60 ml in 1 bottle, plastic of Sertraline Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is solution, concentrate and is administered via oral form.

    Is NDC 65862-224 included in the NDC Directory?

    Yes, Sertraline Hydrochloride with product code 65862-224 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on October 31, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-224-20?

    The 11-digit format is 65862022420. 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
    5-3-265862-224-205-4-265862-0224-20