Bupropion Hydrochloride SR (bupropion hydrochloride) NDC 71610-582

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-582Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0582Add 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
71610-582-42	71610058242	1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-582-42)Marketed from Aug 24, 2026
71610-582-83	71610058283	3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-582-83)Marketed from Jul 15, 2021

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 SRSuffix: SR
Generic name (nonproprietary): bupropion hydrochloride
Active ingredients: Bupropion hydrochloride — 200 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205794
Marketing start: Apr 15, 2021
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 71610-582_9aaffdfd-50f0-417b-805c-2fe7a8267099SPL ID 9aaffdfd-50f0-417b-805c-2fe7a8267099SPL set ID 5f8b3313-0286-499f-9235-02cdc0eb063bRxCUI 993518, 993536UNII 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

N471610058242 followed by a unit qualifier and the quantity

Package 71610-0582-42. 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 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14 )] . Bupropion hydrochloride extended-release…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205794

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

FDA NDC Directory listings under ANDA 205794
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-8473
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-3787
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-175
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-174
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-176
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-576
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Northwind Health Company, LLC	82868-019
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-1866
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-7130
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Dr. Reddys Laboratories Inc.	43598-537
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Dr. Reddys Laboratories Inc.	43598-536
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Film coated, Extended releaseOral	Dr. Reddys Laboratories Inc.	43598-538
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	72162-1529
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-6871
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-6872
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-158
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4056
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-7793
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-7807
Bupropion Hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-1984

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