Prescription drug · ANDA

bupropion Hydrochloride NDC 71610-866

Bupropion hydrochloride 75 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-866Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0866Add 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
71610-866-53716100866537161008665360 TABLET in 1 BOTTLE (71610-866-53)Marketed from Nov 21, 2024
71610-866-60716100866607161008666090 TABLET in 1 BOTTLE (71610-866-60)Marketed from Nov 21, 2024
71610-866-707161008667071610086670120 TABLET in 1 BOTTLE (71610-866-70)Marketed from Nov 21, 2024
71610-866-807161008668071610086680180 TABLET in 1 BOTTLE (71610-866-80)Marketed from Nov 21, 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
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 206975
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 71610-866_d103c1fe-4d4c-48e2-8e30-494b19dd7e52SPL ID d103c1fe-4d4c-48e2-8e30-494b19dd7e52SPL set ID d0eada89-e302-4ba3-bef0-e8c69af8206eRxCUI 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

N471610086653 followed by a unit qualifier and the quantity

Package 71610-0866-53. 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 an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 ) 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) ].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-866

What is NDC 71610-866?
71610-866 is the product NDC for bupropion Hydrochloride, Bupropion hydrochloride 75 mg/1 tablet, 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 206975

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

FDA NDC Directory listings under ANDA 206975
ProductStrengthForm · routeLabelerProduct NDC
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralCoupler LLC67046-1672
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-994
bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralBryant Ranch Prepack71335-0791
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7529
bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralBryant Ranch Prepack72162-2400
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralBryant Ranch Prepack72162-2401
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7530
bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralBryant Ranch Prepack71335-2867
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralBryant Ranch Prepack71335-2875
bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-191
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-192
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralCoupler LLC67046-1562
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralCoupler LLC67046-1587
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-544
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralBryant Ranch Prepack71335-2690
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralChartwell RX, LLC62135-723
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralNorthwind Health Company, LLC51655-390
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralChartwell RX, LLC62135-724
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-899

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