Prescription drug · NDA
BUPROPION HCl ER (XL) (Bupropion hcl er) NDC 70756-830
Bupropion hydrochloride 450 mg/1 · Tablet, Extended release · Oral · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-830-16 | 7075608301670756083016 | 16000 TABLET, EXTENDED RELEASE in 1 BOX (70756-830-16)Marketed from May 1, 2026 | |
| 70756-830-30 | 7075608303070756083030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70756-830-30)Marketed from May 1, 2026 |
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 HCl ER (XL)
- Generic name (nonproprietary)
- bupropion hcl er
- Active ingredients
- Bupropion hydrochloride — 450 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Lifestar Pharma LLCNDC labeler code 70756
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022497
- 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 70756-830_ee47c513-8459-4292-b727-111b0bd1dbccSPL ID ee47c513-8459-4292-b727-111b0bd1dbccSPL set ID df959e1b-3f6d-42cf-8521-fe03b5a4ceb8RxCUI 1232585UNII ZG7E5POY8OUPC 0370756830306
- 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
N470756083016followed by a unit qualifier and the quantityPackage 70756-0830-16. 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 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 established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14)] . The physician who elects to use bupropion h…
Excerpt only. Read the full label for complete information.
About NDC 70756-830
- What is NDC 70756-830?
- 70756-830 is the product NDC for BUPROPION HCl ER (XL) (bupropion hcl er), Bupropion hydrochloride 450 mg/1 tablet, extended release, listed with the FDA by Lifestar Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BUPROPION HCl ER (XL) (BUPROPION HCl ER).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Lifestar Pharma LLC, NDC labeler code 70756. 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 HCl ER (XL)?
- 2 other product NDCs are listed under this name. See all BUPROPION HCl ER (XL) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other BUPROPION HCl ER (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) |
|---|---|---|---|---|---|
| Bupropion HCL ER (XL) | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Direct_RX | 72189-539 | 72189-0539-3072189-0539-90 |
| Bupropion HCL ER (XL) | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 61919-558 | 61919-0558-3061919-0558-6061919-0558-72+1 more |
Other NDCs under NDA 022497
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 |
|---|---|---|---|---|
| bupropion hydrochloride | Bupropion hydrochloride 450 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-248 |
| Forfivo XLbupropion hydrochloride | Bupropion hydrochloride 450 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-247 |