NDC codes

FDA NDC Directory
Product NDC (as listed)72189-457Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0457Add 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
72189-457-30721890457307218904573030 TABLET, FILM COATED in 1 BOTTLE (72189-457-30)Marketed from Mar 30, 2023

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 HCL
Generic name (nonproprietary)
bupropion hcl
Active ingredients
Bupropion hydrochloride — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Direct_RxNDC labeler code 72189
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 72189-457_2c4dd247-ae5a-fe93-e063-6394a90a937cSPL ID 2c4dd247-ae5a-fe93-e063-6394a90a937cSPL set ID f820ad7d-3c88-4a4f-e053-6294a90aef7bRxCUI 993687UNII 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

N472189045730 followed by a unit qualifier and the quantity

Package 72189-0457-30. 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 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 72189-457

What is NDC 72189-457?
72189-457 is the product NDC for Bupropion HCL, Bupropion hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Bupropion HCL.
What is the active ingredient?
Bupropion hydrochloride.
Who is the labeler?
Direct_Rx, NDC labeler code 72189. 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 HCL?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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 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
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2097

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