NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2457Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2457Add 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
71335-2457-17133524570160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-1)Marketed from Aug 20, 2024
71335-2457-27133524570290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-2)Marketed from Aug 20, 2024
71335-2457-37133524570330 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-3)Marketed from Aug 20, 2024
71335-2457-471335245704120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-4)Marketed from Aug 20, 2024
71335-2457-57133524570545 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-5)Marketed from Aug 20, 2024
71335-2457-671335245706180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-6)Marketed from Aug 20, 2024
71335-2457-77133524570728 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-7)Marketed from Aug 20, 2024
71335-2457-87133524570856 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-8)Marketed from Aug 20, 2024
71335-2457-971335245709100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-9)Marketed from Aug 20, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride150 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216800
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 71335-2457_ad9bfc16-be7f-4476-be28-8e7f2f4f3f73SPL ID ad9bfc16-be7f-4476-be28-8e7f2f4f3f73SPL set ID 4c9a5dc3-bebe-431a-b550-ce46c6c6b01eRxCUI 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

N471335245701 followed by a unit qualifier and the quantity

Package 71335-2457-01. 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 . 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-release ta

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216800

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

FDA NDC Directory listings under ANDA 216800
ProductStrengthForm · routeLabelerProduct NDC
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7349
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2649
Bupropion HCL ER(SR)Bupropion hydrochloride 100 mg/1Tablet, Extended releaseOralDriectRx72189-676
Bupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2400
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7423
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7422
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8601
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8602
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralCoupler LLC67046-1572
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2496
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4081
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4093
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralCoupler LLC67046-1273
Bupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-068
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-066
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-067
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8769

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