What is NDC 0615-8504?

0615-8504 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 150 mg/1 tablet, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?

171 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bupropion Hydrochloride NDC 0615-8504

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8504Add 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
0615-8504-05	0061585040500615850405	15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-05)Marketed from Jul 16, 2024
0615-8504-39	0061585043900615850439	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-39)Marketed from Mar 15, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): bupropion hydrochloride
Active ingredients: Bupropion hydrochloride — 150 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211020
Marketing start: Aug 1, 2022
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 0615-8504_31890576-e68d-4449-b0dd-205175720f6bSPL ID 31890576-e68d-4449-b0dd-205175720f6bSPL set ID aeb506f8-97c2-409a-aac9-5a73c840e8f3RxCUI 993541, 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

N400615850405 followed by a unit qualifier and the quantity

Package 00615-8504-05. 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 Aug 12, 2024. 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 maintena…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8504

What is NDC 0615-8504?: 0615-8504 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 150 mg/1 tablet, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bupropion Hydrochloride.
What is the active ingredient?: Bupropion hydrochloride.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?: 171 other product NDCs are listed under this name. See all Bupropion Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4739	70518-4739-00
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1143	67046-1143-03
Bupropion Hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	59651-511	59651-0511-0559651-0511-3059651-0511-90
Bupropion Hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	59651-512	59651-0512-0559651-0512-3059651-0512-90
Bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1273	67046-1273-03
Bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-014	87441-0014-01
bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4674	70518-4674-0070518-4674-0170518-4674-02
Bupropion Hydrochloride	Bupropion hydrochloride 75 mg/1	Tablet, Film coatedOral	Amici Pharma, Inc.	69292-601	69292-0601-01
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	Amici Pharma, Inc.	69292-602	69292-0602-01
bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1672	67046-1672-03

All 172 Bupropion Hydrochloride NDCs

Other NDCs under ANDA 211020

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

FDA NDC Directory listings under ANDA 211020
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8505
bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-862
bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-863
bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4343
bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4674
bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-3153