Prescription drug · NDA
Forfivo XL (Bupropion hydrochloride) NDC 24979-247
Bupropion hydrochloride 450 mg/1 · Tablet, Film coated, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24979-247-06 | 24979024706 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-247-06)Marketed from Dec 15, 2023 |
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)
- Forfivo XLSuffix: XL
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 450 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 24979
- 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 24979-247_96a5dcb3-5d09-4357-96e3-8005ef094b2cSPL ID 96a5dcb3-5d09-4357-96e3-8005ef094b2cSPL set ID 80b01182-dc94-4990-8ebb-55c306d7e536RxCUI 1232585, 1232591UNII ZG7E5POY8OUPC 0324979247069
- 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
N424979024706followed by a unit qualifier and the quantityPackage 24979-0247-06. 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)
FORFIVO 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 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 FO…
Excerpt only. Read the full label for complete information.
About NDC 24979-247
- What is NDC 24979-247?
- 24979-247 is the product NDC for Forfivo XL (bupropion hydrochloride), Bupropion hydrochloride 450 mg/1 tablet, film coated, extended release, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Forfivo XL (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 24979. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Forfivo XL?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 HCl ER (XL)bupropion hcl er | Bupropion hydrochloride 450 mg/1 | Tablet, Extended releaseOral | Lifestar Pharma LLC | 70756-830 |
| bupropion hydrochloride | Bupropion hydrochloride 450 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-248 |