Quick answers
- What is Focalin XR?
- Focalin XR is a brand name of Dexmethylphenidate hydrochloride, a prescription medicine. The FDA NDC Directory lists 16 Focalin XR products in 8 strengths and forms.
- Who makes Focalin XR?
- Sandoz holds the FDA application for Focalin XR (NDA021802, approved May 26, 2005). 1 other company (repackagers or distributors) also list Focalin XR products.
- Is there a generic or store brand of Focalin XR?
- Yes. The FDA NDC Directory lists 70 other products with the same active ingredients, strength and form as a Focalin XR product, 70 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Focalin XR?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 7 Focalin 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 Focalin XR been recalled?
- FDA enforcement reports list 1 recall of Focalin XR products; the newest started June 1, 2026. A recall usually concerns specific lots, not every product.
What Focalin XR is
Each Focalin 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.
Dexmethylphenidate hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dexmethylphenidate hydrochloride 10 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
| dexmethylphenidate hydrochloride 15 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
| dexmethylphenidate hydrochloride 20 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
| dexmethylphenidate hydrochloride 25 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
| dexmethylphenidate hydrochloride 30 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
| dexmethylphenidate hydrochloride 35 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
| dexmethylphenidate hydrochloride 40 mg capsule, extended release (oral) | Focalin XR | 7 products, 7 companies | DailyMed |
| dexmethylphenidate hydrochloride 5 mg capsule, extended release (oral) | Focalin XR | 9 products, 8 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dexmethylphenidate hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021802 | Sandoz | May 26, 2005 | 16 |
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 |
|---|---|---|
| dexmethylphenidate hydrochloride 10 mg capsule, extended release | Brand: Focalin XR | $4.76 per capsule Generic of the same strength and form: $1.39 per capsule |
| dexmethylphenidate hydrochloride 15 mg capsule, extended release | Brand: Focalin XR | $4.91 per capsule Generic of the same strength and form: $0.8519 per capsule |
| dexmethylphenidate hydrochloride 20 mg capsule, extended release | Brand: Focalin XR | $4.91 per capsule Generic of the same strength and form: $1.55 per capsule |
| dexmethylphenidate hydrochloride 25 mg capsule, extended release | Brand: Focalin XR | $5.13 per capsule Generic of the same strength and form: $1.99 per capsule |
| dexmethylphenidate hydrochloride 30 mg capsule, extended release | Brand: Focalin XR | $4.73 per capsule Generic of the same strength and form: $1.44 per capsule |
| dexmethylphenidate hydrochloride 40 mg capsule, extended release | Brand: Focalin XR | $5.42 per capsule Generic of the same strength and form: $1.47 per capsule |
| dexmethylphenidate hydrochloride 5 mg capsule, extended release | Brand: Focalin XR | $4.70 per capsule Generic of the same strength and form: $0.9850 per capsule |
NADAC list of November 4, 2026; these prices took effect between September 30, 2026 and 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 Focalin XR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Focalin XR products.
- Novartis Pharmaceuticals Corporation8 products
- Sandoz Inc8 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 1, 2026 · Class III · Ongoing · D-0608-2026
Labeling: Incorrect or Missing Lot and/or Exp Date
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 — Sandoz Inc
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.