Quick answers
- What is Naprelan?
- Naprelan is a brand name of Naproxen, a prescription medicine. The FDA NDC Directory lists 5 Naprelan products in 3 strengths and forms.
- Who makes Naprelan?
- Twi Pharms holds the FDA application for Naprelan (NDA020353, approved January 5, 1996). 1 other company (repackagers or distributors) also list Naprelan products.
- Is there a generic or store brand of Naprelan?
- Yes. The FDA NDC Directory lists 8 other products with the same active ingredients, strength and form as a Naprelan product, 8 of them generic. Ask your pharmacist whether one is right for you.
- Has Naprelan been recalled?
- No recall linked to Naprelan products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Naprelan is
Each Naprelan product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Naproxen · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| naproxen sodium 375 mg tablet, film coated, extended release (oral) | Naprelan | 4 products, 4 companies | DailyMed |
| naproxen sodium 500 mg tablet, film coated, extended release (oral) | Naprelan | 3 products, 3 companies | DailyMed |
| naproxen sodium 750 mg tablet, film coated, extended release (oral) | Naprelan | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Naproxen →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020353 | Twi Pharms | January 5, 1996 | 5 |
Companies that list Naprelan
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Naprelan products.
- Upsher-Smith Laboratories, LLC3 products
- Almatica Pharma LLC2 products
Recalls
No recall linked to Naprelan products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.