Prescription drug · ANDA
buPropion Hydrochloride XL (bupropion hydrochloride) NDC 72516-035
Bupropion hydrochloride 150 mg/1 · Tablet, Extended release · Oral · Oryza pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72516-035-03 | 72516003503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-03)Marketed from Oct 1, 2020 | |
| 72516-035-09 | 72516003509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-09)Marketed from Oct 1, 2020 | |
| 72516-035-50 | 72516003550 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-50)Marketed from Oct 1, 2020 |
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 XLSuffix: XL
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 150 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Oryza pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211200
- 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 72516-035_47afeb95-a677-8969-e063-6294a90a7b2dSPL ID 47afeb95-a677-8969-e063-6294a90a7b2dSPL set ID 004d8121-59d4-46c4-acb8-b2dd097bf556RxCUI 993541, 993557UNII ZG7E5POY8OUPC 0372516036096, 0372516036508, 0372516035037, 0372516035099, 0372516035501, 0372516036034
- 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
N472516003503followed by a unit qualifier and the quantityPackage 72516-0035-03. 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 (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) (1.1) prevention of seasonal affective disorder (SAD) ( 1.2) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) 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 formulation of bupropion in the maintenance…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211200
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 XLbupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Oryza pharmaceuticals Inc. | 72516-036 |