NDC codes

FDA NDC Directory
Product NDC (as listed)63187-521Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0521Add 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
63187-521-306318705213030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-30)Marketed from Dec 1, 2018
63187-521-606318705216060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-60)Marketed from Dec 1, 2018
63187-521-906318705219090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-90)Marketed from Dec 1, 2018

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
Generic name (nonproprietary)
bupropion
Active ingredients
Bupropion hydrochloride — 300 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201567
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 63187-521_001c902a-af30-40fb-bb22-cc18bd8fc94cSPL ID 001c902a-af30-40fb-bb22-cc18bd8fc94cSPL set ID 47ceb7e1-b2f7-47f8-8b6a-85eea36606b8RxCUI 993557UNII 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

N463187052130 followed by a unit qualifier and the quantity

Package 63187-0521-30. 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)

1. INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder Bupropion hydrochloride extended-release tablets, USP (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4 week controlled inpatient trials and one 6 week controlled outpatient trial of adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-521

What is NDC 63187-521?
63187-521 is the product NDC for bupropion, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
bupropion.
What is the active ingredient?
Bupropion hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. 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?
7 other product NDCs are listed under this name. See all bupropion 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
bupropionbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-35751655-0357-2651655-0357-52
bupropionBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-83665841-0836-0565841-0836-0665841-0836-10+1 more
bupropionBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-35368382-0353-0568382-0353-0668382-0353-10+1 more
bupropionbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralProficient Rx LP71205-56571205-0565-3071205-0565-6071205-0565-90
bupropionbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-080171335-0801-0171335-0801-0271335-0801-03+3 more
bupropionBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-78065841-0780-0565841-0780-0665841-0780-10+1 more
bupropionBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-35468382-0354-0568382-0354-0668382-0354-10+1 more

Other NDCs under ANDA 201567

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

FDA NDC Directory listings under ANDA 201567
ProductStrengthForm · routeLabelerProduct NDC
bupropionBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-353
bupropionBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-354
bupropionBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-780
bupropionBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-836

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