NDC Package 53002-1520-3 Sertraline Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

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:
53002-1520-3
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Sertraline Hydrochloride
Usage Information:
Sertraline hydrochloride tablets are 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)
11-Digit NDC Billing Format:
53002152003
Labeler Name:
Rpk Pharmaceuticals, Inc.
Sample Package:
No
Start Marketing Date:
02-09-2017
Listing Expiration Date:
12-31-2024
Exclude Flag:
E
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.

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Frequently Asked Questions

What is NDC 53002-1520-3?

The NDC Packaged Code 53002-1520-3 is assigned to a package of 30 tablet, film coated in 1 bottle of Sertraline Hydrochloride, labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 53002-1520 included in the NDC Directory?

No, Sertraline Hydrochloride with product code 53002-1520 is excluded from the NDC Directory for failure to respond to FDA's requests for correction to deficient or non-compliant submissions. The product was first marketed by Rpk Pharmaceuticals, Inc. on February 09, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53002-1520-3?

The 11-digit format is 53002152003. 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 5-4-1 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
5-4-153002-1520-35-4-253002-1520-03