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  5. NDC Package Code: 69097-438-02 Sertraline Hydrochloride

NDC Package 69097-438-02 Sertraline Hydrochloride

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
69097-438-02
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
69097-438
Proprietary Name:
Sertraline Hydrochloride
Non-Proprietary Name:
Sertraline Hydrochloride
Substance Name:
Sertraline Hydrochloride
Usage Information:
Sertraline hydrochloride is indicated for the treatment of the following [see Clinical Studies (14)]:Major depressive disorder (MDD) in adultsObsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older
11-Digit NDC Billing Format:
69097043802
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Cipla Usa Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
SERTRALINE HYDROCHLORIDE 150 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA218853
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-17-2025
Listing Expiration Date:
12-31-2026
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.

Frequently Asked Questions

What is NDC 69097-438-02?

The NDC Packaged Code 69097-438-02 is assigned to a package of 30 capsule in 1 bottle of Sertraline Hydrochloride, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is capsule and is administered via oral form.

Is NDC 69097-438 included in the NDC Directory?

Yes, Sertraline Hydrochloride with product code 69097-438 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on July 17, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 69097-438-02?

The 11-digit format is 69097043802. 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
5-3-269097-438-025-4-269097-0438-02