Quick answers
- What is Dexmethylphenidate hydrochloride used for?
- The FDA-approved label (Focalin, Sandoz Inc, May 30, 2024) says: “Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) […]. Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dexmethylphenidate hydrochloride have a boxed warning?
- Yes. The FDA label for Focalin has a boxed warning (“WARNING: ABUSE, MISUSE, AND ADDICTION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dexmethylphenidate hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dexmethylphenidate hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 1, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Dexmethylphenidate hydrochloride?
- 15 companies list prescription products of Dexmethylphenidate hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Sandoz Inc and Lannett Company, Inc..
What Dexmethylphenidate hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) […]. Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
— FDA label: Focalin, Sandoz Inc, effective May 30, 2024. Read the full label on DailyMed →
The FDA has 39 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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: ABUSE, MISUSE, AND ADDICTION
. Read it on the full label →
39 of 39 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 114 in the FDA NDC Directory |
| Brand names | Focalin XR, Focalin |
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 | Generic | $1.39 per capsule |
| dexmethylphenidate hydrochloride 10 mg capsule, extended release | Brand: Focalin XR | $4.76 per capsule |
| dexmethylphenidate hydrochloride 10 mg tablet | Generic | $0.3397 per tablet |
| dexmethylphenidate hydrochloride 10 mg tablet | Brand: Focalin | $1.33 per tablet |
| dexmethylphenidate hydrochloride 15 mg capsule, extended release | Generic | $0.8519 per capsule |
| dexmethylphenidate hydrochloride 15 mg capsule, extended release | Brand: Focalin XR | $4.91 per capsule |
| dexmethylphenidate hydrochloride 2.5 mg tablet | Generic | $0.1890 per tablet |
| dexmethylphenidate hydrochloride 2.5 mg tablet | Brand: Focalin | $0.6499 per tablet |
| dexmethylphenidate hydrochloride 20 mg capsule, extended release | Generic | $1.55 per capsule |
| dexmethylphenidate hydrochloride 20 mg capsule, extended release | Brand: Focalin XR | $4.91 per capsule |
| dexmethylphenidate hydrochloride 25 mg capsule, extended release | Generic | $1.99 per capsule |
| dexmethylphenidate hydrochloride 25 mg capsule, extended release | Brand: Focalin XR | $5.13 per capsule |
| dexmethylphenidate hydrochloride 30 mg capsule, extended release | Generic | $1.44 per capsule |
| dexmethylphenidate hydrochloride 30 mg capsule, extended release | Brand: Focalin XR | $4.73 per capsule |
| dexmethylphenidate hydrochloride 35 mg capsule, extended release | Generic | $2.11 per capsule |
| dexmethylphenidate hydrochloride 40 mg capsule, extended release | Generic | $1.47 per capsule |
| dexmethylphenidate hydrochloride 40 mg capsule, extended release | Brand: Focalin XR | $5.42 per capsule |
| dexmethylphenidate hydrochloride 5 mg capsule, extended release | Generic | $0.9850 per capsule |
| dexmethylphenidate hydrochloride 5 mg capsule, extended release | Brand: Focalin XR | $4.70 per capsule |
| dexmethylphenidate hydrochloride 5 mg tablet | Generic | $0.2626 per tablet |
| dexmethylphenidate hydrochloride 5 mg tablet | Brand: Focalin | $0.9225 per tablet |
NADAC list of November 4, 2026; these prices took effect between May 20, 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack23 products
- Sandoz Inc19 products
- Lannett Company, Inc.8 products
- Granules Pharmaceuticals Inc.8 products
- Novartis Pharmaceuticals Corporation8 products
- Teva Pharmaceuticals USA, Inc.8 products
- Camber Pharmaceuticals, Inc.8 products
- Par Health USA, LLC8 products
- Amneal Pharmaceuticals of New York LLC7 products
- KVK-Tech, Inc.3 products
- Cranbury Pharmaceuticals, LLC3 products
- Lupin Pharmaceuticals, Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Ascend Laboratories, LLC3 products
- Nivagen Pharmaceuticals, Inc.2 products
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 |
|---|---|---|---|
| NDA021278 FOCALIN | Sandoz | November 13, 2001 | 20, latest October 13, 2023 2023: Labeling · 2023: Labeling · 2021: Labeling |
| NDA021802 FOCALIN XR | Sandoz | May 26, 2005 | 25, latest September 23, 2025 2025: Labeling · 2023: Labeling · 2023: Labeling |
Generic approvals (15)
- ANDA078992Platinum · November 18, 2013
- ANDA078908Teva Pharms USA · November 19, 2013
- ANDA202731Teva Pharms USA · November 19, 2013
- ANDA079108Impax Labs Inc · November 21, 2013
- ANDA201231Sun Pharm Industries · September 24, 2015
- ANDA204534Novel Labs Inc · December 4, 2015
- ANDA206931Abhai LLC · December 4, 2015
- ANDA207901Tris Pharma Inc · August 26, 2016
- ANDA202842Ph Health · November 30, 2016
- ANDA203614Impax Labs Inc · July 5, 2017
- ANDA209211Cediprof Inc · September 19, 2018
- ANDA210279Adare Pharms Inc · October 9, 2018
- ANDA212631Alkem Labs Ltd · July 19, 2019
- ANDA213813Granules · September 9, 2020
- ANDA215523Ascent Pharms Inc · December 8, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Focalin, Sandoz Inc, effective May 30, 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 →