Prescription drug · NDA AUTHORIZED GENERIC
Sumatriptan Succinate and Naproxen Sodium NDC 44183-850
Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 · Tablet · Oral · Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44183-850-09 | 4418308500944183085009 | 9 TABLET in 1 BOTTLE (44183-850-09)Marketed from Feb 15, 2018 |
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)
- Sumatriptan Succinate and Naproxen Sodium
- Generic name (nonproprietary)
- sumatriptan succinate and naproxen sodium
- Active ingredients
- Sumatriptan succinate — 85 mg/1Naproxen sodium — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Currax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDC labeler code 44183
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication 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 44183-850_e0a82608-7b67-4d15-a04a-16e6c341c621SPL ID e0a82608-7b67-4d15-a04a-16e6c341c621SPL set ID 5762bbe6-bddf-495c-adf8-9096f98a3a9cRxCUI 849450UNII J8BDZ68989, 9TN87S3A3CUPC 0344183850091
- 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
N444183085009followed by a unit qualifier and the quantityPackage 44183-0850-09. 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)
Sumatriptan and Naproxen Sodium Tablets is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Sumatriptan and Naproxen Sodium Tablets 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 cluste…
Excerpt only. Read the full label for complete information.
About NDC 44183-850
- What is NDC 44183-850?
- 44183-850 is the product NDC for Sumatriptan Succinate and Naproxen Sodium, Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 tablet, listed with the FDA by Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sumatriptan Succinate and Naproxen Sodium.
- What is the active ingredient?
- Sumatriptan succinate, Naproxen sodium.
- Who is the labeler?
- Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven, NDC labeler code 44183. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sumatriptan Succinate and Naproxen Sodium?
- 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 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 |
|---|---|---|---|---|
| Treximetsumatriptan succinate and naproxen sodium | Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 | Tablet, Film coatedOral | Currax Pharmaceuticals LLC | 42847-850 |