Sertraline Hcl Capsule
NDC Package 69238-2791-1

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

Package Information

Sertraline Hcl (sertraline) capsules 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 capsule delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2791 and is authorized under FDA application ANDA219655.

Identification & Billing

NDC Package Code
69238-2791-1
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
69238-2791
11-Digit Billing Format
69238279101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sertraline Hcl
Non-Proprietary Name
Sertraline
Substance Name
Sertraline Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SERTRALINE HYDROCHLORIDE 200 mg/1
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
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219655
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-02-2026
Listing Expiration
12-31-2027
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 69238-2791-1 identifies a specific commercial package of 30 capsule in 1 bottle of Sertraline Hcl, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule 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 Amneal Pharmaceuticals Ny Llc on February 02, 2026. The current certification is valid through December 31, 2027.

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 Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238279101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-4-1)
69238-2791-1
11-Digit CMS (5-4-2)
69238-2791-01

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