Prescription drug · NDA
Treximet NDC 42847-850
sumatriptan succinate and naproxen sodium · Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 · Tablet, Film coated · Oral · Currax Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42847-850-09 | 42847085009 | 9 TABLET, FILM COATED in 1 BOTTLE (42847-850-09)Marketed from Apr 25, 2008 |
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)
- Treximet
- Generic name (nonproprietary)
- sumatriptan succinate and naproxen sodium
- Active ingredients
- Sumatriptan succinate — 85 mg/1Naproxen sodium — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Currax Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021926
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 42847-850_ed866a98-f50a-48af-8ad7-9b139a8a6bc5SPL ID ed866a98-f50a-48af-8ad7-9b139a8a6bc5SPL set ID 42ddf376-8dc0-4236-be2a-0c6ae92ece04RxCUI 849450, 849452UNII J8BDZ68989, 9TN87S3A3CUPC 0342847850098
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Serotonin-1b and Serotonin-1d Receptor Agonist
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
N442847085009followed by a unit qualifier and the quantityPackage 42847-0850-09. 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)
TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. TREXIMET is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) Not indicated for the treatment of cluster headache. ( 1 ) Limitations of Use: Use only if a clear diag…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021926
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 |
|---|---|---|---|---|
| Sumatriptan Succinate and Naproxen Sodium | Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 | TabletOral | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 44183-850 |