NDC codes

FDA NDC Directory
Product NDC (as listed)44183-850Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44183-0850Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
44183-850-0944183085009441830850099 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

Generic name (nonproprietary)
sumatriptan succinate and naproxen sodium
Active ingredients
Sumatriptan succinate — 85 mg/1Naproxen sodium — 500 mg/1
Dosage form
Tablet
Route
Oral
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

N444183085009 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 021926
ProductStrengthForm · routeLabelerProduct NDC
Treximetsumatriptan succinate and naproxen sodiumSumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1Tablet, Film coatedOralCurrax Pharmaceuticals LLC42847-850

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