NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7110Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7110Add 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
50090-7110-05009071100090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7110-0)Marketed from Mar 11, 2024
50090-7110-15009071100130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7110-1)Marketed from Mar 11, 2024
50090-7110-25009071100260 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7110-2)Marketed from Mar 11, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)Suffix: (XL)
Generic name (nonproprietary)
bupropion hydrochloride
Active ingredients
Bupropion hydrochloride150 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210081
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 50090-7110_4ecbc3fb-72e9-430a-9903-1da1e65ed1c7SPL ID 4ecbc3fb-72e9-430a-9903-1da1e65ed1c7SPL set ID 8ae81b03-b447-4a3f-8ed9-ebf75ee52b49RxCUI 993541UNII 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

N450090711000 followed by a unit qualifier and the quantity

Package 50090-7110-00. 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) are 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 main

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210081

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

FDA NDC Directory listings under ANDA 210081
ProductStrengthForm · routeLabelerProduct NDC
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5334
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7109
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralProficient Rx LP71205-968
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralProficient Rx LP71205-967

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