buPropion Hydrochloride XL NDC 72516-036

NDC codes

FDA NDC Directory

Product NDC (as listed)72516-036Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72516-0036Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
72516-036-03	72516003603	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-036-03)Marketed from Sep 6, 2019
72516-036-09	72516003609	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-036-09)Marketed from Sep 6, 2019
72516-036-50	72516003650	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-036-50)Marketed from Sep 6, 2019

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 — 300 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: Sep 6, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 72516-036_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

N472516003603 followed by a unit qualifier and the quantity

Package 72516-0036-03. 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 Nov 25, 2025. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211200

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211200
Product	Strength	Form · route	Labeler	Product NDC
buPropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Oryza pharmaceuticals Inc.	72516-035

buPropion Hydrochloride XL (bupropion hydrochloride) NDC 72516-036