Prescription drug · NDA
Wellbutrin XL (Bupropion hydrochloride) NDC 0187-0731
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0731-07 | 0018707310700187073107 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0731-07)Marketed from Aug 29, 2003 | |
| 0187-0731-30 | 0018707313000187073130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0731-30)Marketed from Aug 29, 2003 |
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)
- Wellbutrin XLSuffix: XL
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021515
- 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 0187-0731_22308f71-fc56-430d-b559-bed47e17a46cSPL ID 22308f71-fc56-430d-b559-bed47e17a46cSPL set ID a435da9d-f6e8-4ddc-897d-8cd2bf777b21RxCUI 993541, 993545, 993557, 993564UNII ZG7E5POY8OUPC 0301870730302, 0301870731309
- 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
N400187073107followed by a unit qualifier and the quantityPackage 00187-0731-07. 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)
Wellbutrin 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) Wellbutrin XL ® (bupropion hydrochloride extended-release) tablets is 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 treatment of MDD was …
Excerpt only. Read the full label for complete information.
About NDC 0187-0731
- What is NDC 0187-0731?
- 0187-0731 is the product NDC for Wellbutrin XL (bupropion hydrochloride), Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Bausch Health US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Wellbutrin XL (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Wellbutrin XL?
- 1 other product NDC are listed under this name. See all Wellbutrin XL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Wellbutrin XL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Wellbutrin XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-0730 | 00187-0730-0700187-0730-3000187-0730-90 |
Other NDCs under NDA 021515
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Wellbutrin XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bausch Health US LLC | 0187-0730 |