NDC codes

FDA NDC Directory
Product NDC (as listed)42847-850Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42847-0850Add 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
42847-850-09428470850099 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
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

N442847085009 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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
Sumatriptan Succinate and Naproxen SodiumSumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1TabletOralCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven44183-850

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