Prescription drug · NDA
Wellbutrin SR (Bupropion hydrochloride) NDC 0173-0135
Bupropion hydrochloride 150 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0135-55 | 00173013555 | 60 TABLET, FILM COATED in 1 BOTTLE (0173-0135-55)Marketed from Nov 15, 1996 |
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 SRSuffix: SR
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020358
- 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 0173-0135_5ffc8b63-7d69-4f3a-bf05-a9c138724a91SPL ID 5ffc8b63-7d69-4f3a-bf05-a9c138724a91SPL set ID cbc8c074-f080-4489-a5ae-207b5fadeba3RxCUI 993503, 993511, 993518, 993528, 993536, 993537UNII ZG7E5POY8OUPC 0301730722003, 0301730135551, 0301730947550
- 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
N400173013555followed by a unit qualifier and the quantityPackage 00173-0135-55. 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 SR (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion 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 )] . The efficacy of WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo‑controlled trial [see Clinical Studies ( 14 )] . WELLBUTRIN SR is an aminoketone antidepressant, indicated for the treatment of major depressiv…
Excerpt only. Read the full label for complete information.
About NDC 0173-0135
- What is NDC 0173-0135?
- 0173-0135 is the product NDC for Wellbutrin SR (bupropion hydrochloride), Bupropion hydrochloride 150 mg/1 tablet, film coated, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Wellbutrin SR (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. 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 SR?
- 2 other product NDCs are listed under this name. See all Wellbutrin SR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Wellbutrin SR 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 SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0722 | 00173-0722-00 |
| Wellbutrin SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0947 | 00173-0947-55 |
Other NDCs under NDA 020358
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 SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0722 |
| Wellbutrin SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0947 |