Prescription drug · NDA AUTHORIZED GENERIC
Bupropion Hydrobromide NDC 68682-581
Bupropion hydrobromide 348 mg/1 · Tablet, Extended release · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-581-30 | 68682058130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-581-30)Marketed from Jun 29, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bupropion Hydrobromide
- Generic name (nonproprietary)
- bupropion hydrobromide
- Active ingredients
- Bupropion hydrobromide — 348 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022108
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68682-581_361893cf-be64-4b2c-a70e-e3ba68e69309SPL ID 361893cf-be64-4b2c-a70e-e3ba68e69309SPL set ID 3ec04240-baef-44d7-8d73-a181171eec43RxCUI 993550, 993567, 993681UNII E70G3G5863
- Pharmacologic class
- Aminoketone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468682058130followed by a unit qualifier and the quantityPackage 68682-0581-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Bupropion Hydrobromide Extended-Release Tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder Bupropion Hydrobromide Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release f…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022108
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aplenzinbupropion hydrobromide | Bupropion hydrobromide 174 mg/1 | Tablet, Extended releaseOral | Bausch Health US, LLC | 0187-5810 |
| Aplenzinbupropion hydrobromide | Bupropion hydrobromide 348 mg/1 | Tablet, Extended releaseOral | Bausch Health US, LLC | 0187-5811 |
| Aplenzinbupropion hydrobromide | Bupropion hydrobromide 522 mg/1 | Tablet, Extended releaseOral | Bausch Health US, LLC | 0187-5812 |
| Bupropion Hydrobromide | Bupropion hydrobromide 174 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-580 |
| Bupropion Hydrobromide | Bupropion hydrobromide 522 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-582 |