NDC codes

FDA NDC Directory
Product NDC (as listed)0527-2430Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-2430Add 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
0527-2430-320052724303230 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-32)Marketed from Jan 31, 2022
0527-2430-4100527243041500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-41)Marketed from Jan 31, 2022
0527-2430-43005272430431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-43)Marketed from Jan 31, 2022
0527-2430-460052724304690 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-46)Marketed from Jan 31, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 (XL)
Generic name (nonproprietary)
bupropion hydrochloride
Active ingredients
Bupropion hydrochloride300 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208652
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 0527-2430_5e3c0247-0f79-454e-b14d-1e7dfd1a765eSPL ID 5e3c0247-0f79-454e-b14d-1e7dfd1a765eSPL set ID 15c4e95a-d203-4caf-b6c7-44792355cb76RxCUI 993541, 993557UNII ZG7E5POY8OUPC 0305272430419, 0305272415461, 0305272430464, 0305272415416, 0305272430327, 0305272430433, 0305272415324, 0305272415430
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

N400527243032 followed by a unit qualifier and the quantity

Package 00527-2430-32. 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 extended-release tablets (XL) is an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) (1.2) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (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 adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208652

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

FDA NDC Directory listings under ANDA 208652
ProductStrengthForm · routeLabelerProduct NDC
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralMullan Pharmaceutical Inc.83301-0024
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralMullan Pharmaceutical Inc.83301-0025
Bupropion hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralVitruvias Therapeutics69680-158
Bupropion hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralVitruvias Therapeutics69680-157
Bupropion hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralLannett Company Inc.0527-2415
Bupropion Hydrochloride (XL)Bupropion hydrochloride 150 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-875
Bupropion Hydrochloride (XL)Bupropion hydrochloride 300 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-876

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