Bupropion Hcl Er(sr) Tablet, Extended Release
NDC Package 72189-676-60

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

Package Information

Bupropion Hcl Er(sr) tablets is bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). This formulation utilizes a tablet, extended release delivery system. Marketed by Driectrx, this product is identified by NDC 72189-676 and is authorized under FDA application ANDA216800.

Identification & Billing

NDC Package Code
72189-676-60
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
72189-676
11-Digit Billing Format
72189067660
RxNorm Crosswalk
  • RxCUI: 993503 - buPROPion HCl 100 MG 12HR Extended Release Oral Tablet
  • RxCUI: 993503 - 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet
  • RxCUI: 993503 - bupropion HCl 100 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Bupropion Hcl Er(sr)
Non-Proprietary Name
Bupropion Hcl Er(sr)
Substance Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BUPROPION HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Driectrx
Product Type
Human Prescription Drug
FDA Application #
ANDA216800
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2026
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 72189-676-60 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Bupropion Hcl Er(sr), a human prescription drug labeled by Driectrx. This tablet, extended release is formulated for oral use and contains bupropion 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 Driectrx on April 30, 2026. The current certification is valid through December 31, 2027.

How is this Driectrx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189067660. 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 (5-3-2)
72189-676-60
11-Digit CMS (5-4-2)
72189-0676-60

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