What is NDC 76420-812?

76420-812 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Asclemed USA, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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?

176 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 76420-812

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-812Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0812Add 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
76420-812-01	7642008120176420081201	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-01)Marketed from May 7, 2024
76420-812-05	7642008120576420081205	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-05)Marketed from May 7, 2024
76420-812-30	7642008123076420081230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-30)Marketed from May 7, 2024
76420-812-60	7642008126076420081260	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-60)Marketed from May 7, 2024
76420-812-90	7642008129076420081290	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-90)Marketed from May 7, 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 Hydrochloride
Generic name (nonproprietary): bupropion hydrochloride
Active ingredients: Bupropion hydrochloride — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077285
Marketing start: Feb 17, 2015
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 76420-812_2dffd9ed-8b4a-a56b-e063-6394a90ae043SPL ID 2dffd9ed-8b4a-a56b-e063-6394a90ae043SPL set ID 637e89e5-8f6e-4392-8045-a778cb9ed138RxCUI 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

N476420081201 followed by a unit qualifier and the quantity

Package 76420-0812-01. 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 Feb 12, 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 maintena…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-812

What is NDC 76420-812?: 76420-812 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Asclemed USA, Inc.. It has 5 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?: Asclemed USA, Inc., NDC labeler code 76420. 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?: 176 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	70518-4674-0070518-4674-01
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 177 Bupropion Hydrochloride NDCs

Other NDCs under ANDA 077285

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

FDA NDC Directory listings under ANDA 077285
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Actavis Pharma, Inc.	45963-142
Bupropion Hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-819
Bupropion Hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	HAWAII REPACK, INC.	85534-0006