Quick answers
- What is Dyanavel XR?
- Dyanavel XR is a brand name of Amphetamine, a prescription medicine. The FDA NDC Directory lists 5 Dyanavel XR products in 5 strengths and forms.
- Who makes Dyanavel XR?
- Tris Pharma Inc holds the FDA application for Dyanavel XR (NDA208147, approved October 19, 2015).
- Is there a generic or store brand of Dyanavel XR?
- Other products of Amphetamine are listed with the FDA, but none in exactly the same strength and form as a Dyanavel XR product.
- What do pharmacies pay for Dyanavel XR?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 5 Dyanavel XR strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Dyanavel XR been recalled?
- No recall linked to Dyanavel XR products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Dyanavel XR is
Each Dyanavel XR 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.
Amphetamine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| amphetamine 10 mg tablet, extended release (oral) | Dyanavel XR | None listed | DailyMed |
| amphetamine 15 mg tablet, extended release (oral) | Dyanavel XR | None listed | DailyMed |
| amphetamine 2.5 mg/mL suspension, extended release (oral) | Dyanavel XR | None listed | DailyMed |
| amphetamine 20 mg tablet, extended release (oral) | Dyanavel XR | None listed | DailyMed |
| amphetamine 5 mg tablet, extended release (oral) | Dyanavel XR | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Amphetamine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA208147 | Tris Pharma Inc | October 19, 2015 | 1 |
| NDA210526 | Tris Pharma Inc | November 4, 2021 | 4 |
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 |
|---|---|---|
| amphetamine 10 mg tablet, extended release | Brand: Dyanavel XR | $14.77 per tablet |
| amphetamine 15 mg tablet, extended release | Brand: Dyanavel XR | $14.81 per tablet |
| amphetamine 2.5 mg/mL suspension, extended release | Brand: Dyanavel XR | $2.75–$2.77 per mL 2 packages, lowest to highest |
| amphetamine 20 mg tablet, extended release | Brand: Dyanavel XR | $14.78 per tablet |
| amphetamine 5 mg tablet, extended release | Brand: Dyanavel XR | $7.85 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 Dyanavel XR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Dyanavel XR products.
- NextWave Pharmaceuticals, Inc5 products
Recalls
No recall linked to Dyanavel XR 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.