Bupropion Hydrochloride
NDC Package 53217-252-90
Package Information
Bupropion Hydrochloride is extended-release tablets USP, (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 tablet (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)]. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 53217-252 and is authorized under FDA application ANDA206674.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 53217 - Aidarex Pharmaceuticals Llc
- 53217-252 - Bupropion Hydrochloride
- 53217-252-90 - 90 TABLET, EXTENDED RELEASE in 1 BOTTLE
- 53217-252 - Bupropion Hydrochloride
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 (53217-252). Click a package code to view its specific billing and regulatory data.
* 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 53217-252-90 identifies a specific commercial package of 90 tablet, extended release in 1 bottle of Bupropion Hydrochloride, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. 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 Aidarex Pharmaceuticals Llc on July 25, 2016. The current certification is valid through December 31, 2019.
How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 53217025290. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
