Bupropion Hydrochloride
NDC Package 76519-1021-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 is 1.1 Major Depressive DisorderBupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). Marketed by H.j. Harkins Company Inc., this product is identified by NDC 76519-1021 and is authorized under FDA application ANDA206556.

Identification & Billing

NDC Package Code
76519-1021-3
Package Description
30 TABLET, EXTENDED RELEASE in 1 CONTAINER
Product Code
76519-1021
11-Digit Billing Format
76519102103
RxNorm Crosswalk
  • RxCUI: 993541 - buPROPion HCl 150 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993541 - 24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet
  • RxCUI: 993541 - bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Bupropion Hydrochloride
Dosage Form
-
Usage Information
1.1 Major Depressive DisorderBupropion hydrochloride extended-release tablets, (XL) are 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)]. 1.2 Seasonal Affective DisorderBupropion hydrochloride extended-release tablets, (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see CLINICAL STUDIES (14.2)].

Regulatory & Marketing

Labeler Name
H.j. Harkins Company Inc.
FDA Application #
ANDA206556
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-03-2017
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76519-1021). Click a package code to view its specific billing and regulatory data.

76519-1021-5
150 TABLET, EXTENDED RELEASE in 1 CONTAINER

* 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 76519-1021-3 identifies a specific commercial package of 30 tablet, extended release in 1 container of Bupropion Hydrochloride, labeled by H.j. Harkins Company 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 H.j. Harkins Company Inc. on January 03, 2017. The current certification is valid through December 31, 2019.

How is this H.j. Harkins Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76519102103. 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)
76519-1021-3
11-Digit CMS (5-4-2)
76519-1021-03

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