Prescription drug · ANDA

Bupropion Hydrochloride NDC 50268-143

Bupropion hydrochloride 100 mg/1 · Tablet, Film coated · Oral · AvPAK

NDC codes

FDA NDC Directory
Product NDC (as listed)50268-143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0143Add 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
50268-143-155026801431550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-143-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-143-11)Marketed from Aug 2, 2017

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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AvPAK
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 50268-143_4b95b3fd-3945-41d9-e063-6294a90a34edSPL ID 4b95b3fd-3945-41d9-e063-6294a90a34edSPL set ID bcb4ef83-f272-4090-8547-9aaf4ab63667RxCUI 993687, 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

N450268014315 followed by a unit qualifier and the quantity

Package 50268-0143-15. 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)

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 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7988
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-774
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6636
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralProficient Rx LP82804-123
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralProficient Rx LP82804-127
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8180
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4152
Bupropion HCLBupropion hydrochloride 100 mg/1Tablet, Film coatedOralDirect_Rx72189-457
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2256
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-781
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-070
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-164
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-746
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-747
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0013
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralAvPAK50268-142
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralCoupler LLC67046-0872
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-880
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1869
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-308

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