Bupropion Hydrochloride Extended Release
NDC Package 10135-704-90
Package Information
Bupropion Hydrochloride Extended Release is bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder.Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride extended-release tablets (XL) [see Warnings and Precautions (5.3)].Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3)].The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) is contraindicated. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-704 and is authorized under FDA application ANDA211200.
Identification & Billing
- 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
- RxCUI: 993557 - buPROPion HCl 300 MG 24HR Extended Release Oral Tablet
- RxCUI: 993557 - 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 10135 - Marlex Pharmaceuticals Inc
- 10135-704 - Bupropion Hydrochloride Extended Release
- 10135-704-90 - 90 TABLET in 1 BOTTLE
- 10135-704 - Bupropion Hydrochloride Extended Release
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 (10135-704). 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 10135-704-90 identifies a specific commercial package of 90 tablet in 1 bottle of Bupropion Hydrochloride Extended Release, labeled by Marlex Pharmaceuticals Inc. 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 Marlex Pharmaceuticals Inc on July 01, 2020. The current certification is valid through December 31, 2022.
How is this Marlex Pharmaceuticals Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135070490. 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.
