NDC codes

FDA NDC Directory
Product NDC (as listed)71610-774Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0774Add 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
71610-774-53716100774537161007745360 TABLET, FILM COATED in 1 BOTTLE (71610-774-53)Marketed from Jan 22, 2024
71610-774-707161007747071610077470120 TABLET, FILM COATED in 1 BOTTLE (71610-774-70)Marketed from Jan 25, 2024
71610-774-807161007748071610077480180 TABLET, FILM COATED in 1 BOTTLE (71610-774-80)Marketed from Jan 25, 2024
71610-774-947161007749471610077494360 TABLET, FILM COATED in 1 BOTTLE (71610-774-94)Marketed from Jan 25, 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 — 75 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076143
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 71610-774_edf166e7-bcf0-4bda-97ea-d9b82140aab3SPL ID edf166e7-bcf0-4bda-97ea-d9b82140aab3SPL set ID 8d80f882-1887-4d73-b09f-e98fd7ef2acbRxCUI 993691UNII 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

N471610077453 followed by a unit qualifier and the quantity

Package 71610-0774-53. 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 tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets 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 )]. Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-774

What is NDC 71610-774?
71610-774 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 75 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-473970518-4739-00
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-114367046-1143-03
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited59651-51159651-0511-0559651-0511-3059651-0511-90
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited59651-51259651-0512-0559651-0512-3059651-0512-90
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralCoupler LLC67046-127367046-1273-03
Bupropion hydrochlorideBupropion hydrochloride 300 mg/1TabletOralUnit Dose Solutions, Inc.87441-01487441-0014-01
bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-467470518-4674-0070518-4674-0170518-4674-02
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralAmici Pharma, Inc.69292-60169292-0601-01
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAmici Pharma, Inc.69292-60269292-0602-01
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralCoupler LLC67046-167267046-1672-03

All 172 Bupropion Hydrochloride NDCs

Other NDCs under ANDA 076143

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

FDA NDC Directory listings under ANDA 076143
ProductStrengthForm · routeLabelerProduct NDC
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralCoupler LLC67046-0872
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralAvPAK50268-142
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-143
Bupropion HCLBupropion hydrochloride 100 mg/1Tablet, Film coatedOralDirect_Rx72189-457
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-340
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralApotex Corp60505-0157
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralApotex Corp60505-0158
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-351
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1566
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-164
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-1143
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0013
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2577
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-070
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1869
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7988
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0182
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6635
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-708
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6636

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