Sertraline Hydrochloride Solution, Concentrate
NDC Package 64980-409-06

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

Package Information

Sertraline Hydrochloride solution is 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). This formulation utilizes a solution, concentrate delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 64980-409 and is authorized under FDA application ANDA078861.

Identification & Billing

NDC Package Code
64980-409-06
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 mL in 1 BOTTLE, PLASTIC
Product Code
64980-409
11-Digit Billing Format
64980040906
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
Non-Proprietary Name
Sertraline Hydrochloride
Substance Name
Sertraline Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SERTRALINE HYDROCHLORIDE 20 mg/mL
Pharmacologic Class
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
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078861
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2008
Listing Expiration
12-31-2026
Exclude Flag
N
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 64980-409-06 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 ml in 1 bottle, plastic of Sertraline Hydrochloride, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This solution, concentrate is formulated for oral use and contains sertraline hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Rising Pharma Holdings, Inc. on October 31, 2008. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980040906. 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)
64980-409-06
11-Digit CMS (5-4-2)
64980-0409-06

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