Sertraline Hydrochloride
NDC Package 71093-143-11

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 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). Marketed by Aci Healthcare Usa, Inc., this product is identified by NDC 71093-143 and is authorized under FDA application ANDA076934.

Identification & Billing

NDC Package Code
71093-143-11
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 60 mL in 1 BOTTLE, DROPPER
Product Code
71093-143
11-Digit Billing Format
71093014311
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
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)

Regulatory & Marketing

Labeler Name
Aci Healthcare Usa, Inc.
FDA Application #
ANDA076934
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2006
Listing Expiration
12-31-2025
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 71093-143-11 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 60 ml in 1 bottle, dropper of Sertraline Hydrochloride, labeled by Aci Healthcare Usa, 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 Aci Healthcare Usa, Inc. on June 30, 2006. The current certification is valid through December 31, 2025.

How is this Aci Healthcare Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71093014311. 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)
71093-143-11
11-Digit CMS (5-4-2)
71093-0143-11

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