What is NDC 72189-539?

72189-539 is the product NDC for Bupropion HCL ER (XL), Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Direct_RX. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bupropion HCL ER (XL)?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bupropion HCL ER (XL) NDC 72189-539

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-539Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0539Add 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	Copy
72189-539-30	7218905393072189053930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-30)Marketed from Mar 1, 2024
72189-539-90	7218905399072189053990	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-90)Marketed from Mar 1, 2024

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 HCL ER (XL)
Generic name (nonproprietary): bupropion hcl er (xl)
Active ingredients: Bupropion hydrochloride — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Direct_RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210015
Marketing start: Mar 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 72189-539_19b02d9d-9104-0442-e063-6394a90a3154SPL ID 19b02d9d-9104-0442-e063-6394a90a3154SPL set ID 129ce80c-0333-873e-e063-6394a90a33e0RxCUI 993557UNII ZG7E5POY8O
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

N472189053930 followed by a unit qualifier and the quantity

Package 72189-0539-30. 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 May 30, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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 treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see CLINICAL STUDIES (14.1)]. 1.2 Se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-539

What is NDC 72189-539?: 72189-539 is the product NDC for Bupropion HCL ER (XL), Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Direct_RX. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bupropion HCL ER (XL).
What is the active ingredient?: Bupropion hydrochloride.
Who is the labeler?: Direct_RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bupropion HCL ER (XL)?: 2 other product NDCs are listed under this name. See all Bupropion HCL ER (XL) NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bupropion HCL ER (XL) NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
BUPROPION HCl ER (XL)bupropion hcl er	Bupropion hydrochloride 450 mg/1	Tablet, Extended releaseOral	Lifestar Pharma LLC	70756-830	70756-0830-1670756-0830-30
Bupropion HCL ER (XL)	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Direct_Rx	61919-558	61919-0558-3061919-0558-6061919-0558-72+1 more

Other NDCs under ANDA 210015

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

FDA NDC Directory listings under ANDA 210015
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Epic Pharma, LLC	42806-414
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Epic Pharma, LLC	42806-416
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-6961
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-6962
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	NuCare Pharmacueticals, Inc.	68071-3594
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Slate Run Pharmaceuticals, LLC	70436-010
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Slate Run Pharmaceuticals, LLC	70436-011
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4014
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-394
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2378
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-377
Bupropion Hydrochloride XLbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	82804-080