Quick answers
- What is Sumatriptan and naproxen sodium used for?
- The FDA-approved label (Treximet, Currax Pharmaceuticals LLC, December 23, 2024) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sumatriptan and naproxen sodium have a boxed warning?
- Yes. The FDA label for Treximet has a boxed warning (“WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sumatriptan and naproxen sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sumatriptan and naproxen sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sumatriptan and naproxen sodium?
- 5 companies list prescription products of Sumatriptan and naproxen sodium in the FDA NDC Directory, including NorthStar RxLLC, Sun Pharmaceutical Industries, Inc. and Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven.
What Sumatriptan and naproxen sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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 …
— FDA label: Treximet, Currax Pharmaceuticals LLC, effective December 23, 2024. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Treximet |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| naproxen sodium 500 mg · sumatriptan succinate 85 mg tablet, film coated | Generic | $10.92 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- NorthStar RxLLC1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven1 product
- Aurobindo Pharma Limited1 product
- Currax Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021926 TREXIMET | Azurity | April 15, 2008 | 12, latest November 21, 2024 2024: Labeling · 2021: Labeling · 2021: Labeling |
Generic approvals (2)
- ANDA207457Aurobindo Pharma Ltd · February 15, 2018
- ANDA202803Sun Pharm · July 20, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 849450, 849452 |
|---|---|
| SPL set ID of the quoted label | 42ddf376-8dc0-4236-be2a-0c6ae92ece04 |
| FDA labels (SPL) | 5 |
| FDA applications | NDA021926, 2 ANDA |
| Active ingredients (FDA) | NAPROXEN / SUMATRIPTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Treximet, Currax Pharmaceuticals LLC, effective December 23, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →