Prescription drug · ANDA
Bupropion Hydrochloride SR (bupropion hydrochloride) NDC 42806-424
Bupropion hydrochloride 100 mg/1 · Tablet, Extended release · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-424-01 | 42806042401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-01)Marketed from Sep 18, 2023 | |
| 42806-424-05 | 42806042405 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-05)Marketed from Sep 18, 2023 | |
| 42806-424-60 | 42806042460 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-60)Marketed from Sep 18, 2023 |
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 Hydrochloride SRSuffix: SR
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Epic Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211347
- 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 42806-424_50036e03-a443-a430-e063-6394a90a72c7SPL ID 50036e03-a443-a430-e063-6394a90a72c7SPL set ID f8ad76a2-9f75-4660-973d-34402f314e9cRxCUI 993503, 993518, 993536UNII ZG7E5POY8OUPC 0342806426050, 0342806426012, 0342806425053, 0342806425015, 0342806424056, 0342806424605, 0342806426609, 0342806424018
- 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
N442806042401followed by a unit qualifier and the quantityPackage 42806-0424-01. 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 Hydrochloride Extended-Release Tablets (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 Tablets (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 )] . Bupropion Hydrochloride Extended-Releas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211347
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 |
|---|---|---|---|---|
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-425 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-426 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1837 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-115 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1870 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1986 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-058 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-059 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-060 |