Bupropion Hydrochloride (xl)
NDC Package 53002-1508-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Bupropion Hydrochloride (xl) is bupropion hydrochloride extended-release tablets (XL) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1508 and is authorized under FDA application ANDA208652.

Identification & Billing

NDC Package Code
53002-1508-3
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
53002-1508
11-Digit Billing Format
53002150803
RxNorm Crosswalk
  • RxCUI: 993557 - buPROPion HCl 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993557 - 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet
  • RxCUI: 993557 - bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Bupropion Hydrochloride (xl)
Dosage Form
-
Usage Information
Bupropion hydrochloride extended-release tablets (XL) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies(14.1)].

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA208652
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2018
Listing Expiration
12-31-2022
Exclude Flag
I
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 53002-1508-3 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Bupropion Hydrochloride (xl), labeled by Rpk Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rpk Pharmaceuticals, Inc. on January 08, 2018. The current certification is valid through December 31, 2022.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002150803. 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)
53002-1508-3
11-Digit CMS (5-4-2)
53002-1508-03

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