Bupropion Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 80425-0539-2

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 (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)]. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Advanced Rx Of Tennessee, Llc, this product is identified by NDC 80425-0539 and is authorized under FDA application ANDA207479.

Identification & Billing

NDC Package Code
80425-0539-2
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
80425-0539
11-Digit Billing Format
80425053902
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 993557 - buPROPion HCl 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993557 - 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet
  • RxCUI: 993557 - bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Bupropion Hydrochloride (xl)
Non-Proprietary Name
Bupropion Hydrochloride
Substance Name
Bupropion Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BUPROPION HYDROCHLORIDE 300 mg/1
Pharmacologic Class
Usage Information
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. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.4)and Drug Interactions (7.6)]. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL). Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see Warnings and Precautions (5.8)].

Regulatory & Marketing

Labeler Name
Advanced Rx Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207479
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-29-2025
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 (80425-0539). Click a package code to view its specific billing and regulatory data.

80425-0539-1
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
80425-0539-3
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 80425-0539-2 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle, plastic of Bupropion Hydrochloride (xl), a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, film coated, 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 Advanced Rx Of Tennessee, Llc on August 29, 2025. The current certification is valid through December 31, 2026.

How is this Advanced Rx Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425053902. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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:

10-Digit Format (5-4-1)
80425-0539-2
11-Digit CMS (5-4-2)
80425-0539-02

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