NDC codes

FDA NDC Directory
Product NDC (as listed)82868-019Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82868-0019Add 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 NDC11-digit (billing)PackageCopy
82868-019-308286800193030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-30)Marketed from Mar 14, 2024
82868-019-608286800196060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-60)Marketed from Oct 19, 2023
82868-019-908286800199090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-90)Marketed from Jan 2, 2025
82868-019-9682868001996180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-96)Marketed from Feb 19, 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 SRSuffix: SR
Generic name (nonproprietary)
bupropion hydrochloride
Active ingredients
Bupropion hydrochloride150 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205794
Marketing start
Listing expires
Other FDA classes
Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 82868-019_549ef654-60b6-05bb-e063-6294a90a22b8SPL ID 549ef654-60b6-05bb-e063-6294a90a22b8SPL set ID 0865f8cf-1d7f-0e67-e063-6294a90a2f4dRxCUI 993518UNII 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

N482868001930 followed by a unit qualifier and the quantity

Package 82868-0019-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride extended-release tablets (SR) are 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-releas

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
ProductStrengthForm · routeLabelerProduct NDC
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-8473
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-3787
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals, Inc.50228-175
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals, Inc.50228-174
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals, Inc.50228-176
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-576
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-582
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-1866
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-7130
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Inc.43598-537
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Inc.43598-536
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Inc.43598-538
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1529
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-6871
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-6872
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-158
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-4056
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-7793
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-7807
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-1984

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