Zoloft Solution, Concentrate
NDC Package 58151-601-35

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

Package Information

Zoloft (sertraline hydrochloride) solution is sertraline is used to treat depression, panic attacks, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder (social phobia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This formulation utilizes a solution, concentrate delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 58151-601 and is authorized under FDA application NDA020990.

Identification & Billing

NDC Package Code
58151-601-35
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 60 mL in 1 BOTTLE, DROPPER
Product Code
58151-601
11-Digit Billing Format
58151060135
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zoloft
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 is used to treat depression, panic attacks, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder (social phobia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Sertraline is known as a selective serotonin reuptake inhibitor (SSRI). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020990
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-21-2024
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 58151-601-35 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 60 ml in 1 bottle, dropper of Zoloft, a human prescription drug labeled by Viatris Specialty Llc. 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 Viatris Specialty Llc on November 21, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sertraline is used to treat depression, panic attacks, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder (social phobia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Sertraline is known as a selective serotonin reuptake inhibitor (SSRI). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58151060135. 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)
58151-601-35
11-Digit CMS (5-4-2)
58151-0601-35

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