Bupropion Hydrochloride Tablet, Extended Release
NDC Package 70436-059-02

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

Bupropion Hydrochloride 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).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)]. This formulation utilizes a tablet, extended release delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-059 and is authorized under FDA application ANDA211347.

Identification & Billing

NDC Package Code
70436-059-02
Package Description
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
70436-059
11-Digit Billing Format
70436005902
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
  • RxCUI: 993518 - buPROPion HCl 150 MG 12HR Extended Release Oral Tablet
  • RxCUI: 993518 - 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Bupropion Hydrochloride SR
Non-Proprietary Name
Bupropion Hydrochloride
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 150 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
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211347
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2020
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70436-059). Click a package code to view its specific billing and regulatory data.

70436-059-01
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
70436-059-05
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
70436-059-22
250 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 70436-059-02 identifies a specific commercial package of 500 tablet, extended release in 1 bottle of Bupropion Hydrochloride SR, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. 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 Slate Run Pharmaceuticals, Llc on November 02, 2020. The current certification is valid through December 31, 2026.

How is this Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436005902. 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)
70436-059-02
11-Digit CMS (5-4-2)
70436-0059-02

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