Bupropion Hydrobromide Tablet, Extended Release
NDC Package 68682-582-30

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

Package Information

Bupropion Hydrobromide tablets is bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a seizure disorder.Bupropion Hydrobromide Extended-Release Tablets 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 hydrobromide extended-release tablets [see Warnings and Precautions (5.3)]. This formulation utilizes a tablet, extended release delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-582 and is authorized under FDA application NDA022108.

Identification & Billing

NDC Package Code
68682-582-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68682-582
11-Digit Billing Format
68682058230

Clinical Specifications

Proprietary Name
Bupropion Hydrobromide
Non-Proprietary Name
Bupropion Hydrobromide
Substance Name
Bupropion Hydrobromide
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 HYDROBROMIDE 522 mg/1
Pharmacologic Class
Usage Information
Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a seizure disorder.Bupropion Hydrobromide Extended-Release Tablets 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 hydrobromide extended-release tablets [see Warnings and Precautions (5.3)]. Bupropion Hydrobromide Extended-Release Tablets 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 hydrobromide extended-release tablets or within 14 days of discontinuing treatment with bupropion hydrobromide extended-release tablets is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrobromide extended-release tablets are used concomitantly with MAOIs. The use of bupropion hydrobromide extended-release tablets within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrobromide extended-release tablets in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.5, 2.6, 2.9), Warnings and Precautions (5.4), and Drug Interactions (7.6)]. Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrobromide extended-release tablets. Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions (5.8)].

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA022108
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
06-29-2026
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 68682-582-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Bupropion Hydrobromide, a human prescription drug labeled by Oceanside Pharmaceuticals. This tablet, extended release is formulated for oral use and contains bupropion hydrobromide 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 Oceanside Pharmaceuticals on June 29, 2026. The current certification is valid through December 31, 2027.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682058230. 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)
68682-582-30
11-Digit CMS (5-4-2)
68682-0582-30

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