Prescription medicine
Dexmethylphenidate Brand names: Focalin
Dexmethylphenidate (Focalin) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $1.45 per dexmethylphenidate ER 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the dexmethylphenidate FDA label on DailyMed (effective May 30, 2024, Sandoz Inc); the NDA 21278 record on Drugs@FDA; every dexmethylphenidate label on DailyMed.
Highlights of the record
FDA label of May 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ABUSE, MISUSE, AND ADDICTION.
Focalin has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin, can result in overdose and death [see Overdosage ( 10 )], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Focalin, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Focalin treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE AND ADDICTION See full prescribing information for complete boxed warning. Focalin has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin, can result in overdose and death ( 5.1 , 9.2 , 10 ):
Before prescribing Focalin, assess each patient’s risk for abuse, misuse, and addiction. […]
Used for
From the label: indications and usageFocalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )].
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 15 mg
- 20 mg
- 25 mg
- 30 mg
- 35 mg
- 40 mg
Extended-release capsule; tablet.
On the market
- Earliest approval on file
- November 13, 2001 Focalin, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first January 29, 2007; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 13 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.45 per capsule Dexmethylphenidate ER 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2015 0 Class I among all firms' recalls; latest June 1, 2026
- FAERS reports
- 4,207 through July 30, 2026
What is dexmethylphenidate used for?
From the label: indications and usageFocalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
Conditions named in the indications of dexmethylphenidate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (Focalin), Sandoz Inc, effective May 30, 2024 (SPL set 2016f5c2-95d2-4655-af65-c588c2bf5e6d), via openFDA; the full label on DailyMed
What does the patient leaflet for dexmethylphenidate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about FOCALIN?FOCALIN may cause serious side effects, including: • Abuse, misuse, and addiction. FOCALIN has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of FOCALIN, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of FOCALIN or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with FOCALIN and will monitor you or your child during treatment. o FOCALIN may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give FOCALIN to anyone else. See “What is FOCALIN?” for more information. o Keep FOCALIN in a safe place and properly dispose of any unused medicine. See “How should I store FOCALIN?” for more information. o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting FOCALIN. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking FOCALIN. • Increased blood pressure and heart rate. […]
From the patient leaflet: How should I store FOCALIN?Store FOCALIN in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). • Protect from light and moisture. • Dispose of remaining, unused, or expired FOCALIN by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix FOCALIN with an undesirable, nontoxic substance, such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and throw away FOCALIN in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. • Keep FOCALIN and all medicines out of the reach of children.
Source: FDA drug label (Focalin), Sandoz Inc, effective May 30, 2024 (SPL set 2016f5c2-95d2-4655-af65-c588c2bf5e6d), via openFDA; the full label on DailyMed
Is there a generic for dexmethylphenidate (Focalin)?
The FDA approved the first generic dexmethylphenidate on January 29, 2007. 21 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dexmethylphenidate from 13 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2001 earliest approval on file
- 2007 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dexmethylphenidate (Focalin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.45 per Dexmethylphenidate ER 10 mg capsule, up 4% from $1.40 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dexmethylphenidate ER 15 mg capsule (generic)
- Focalin XR 30 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dexmethylphenidate 10 mg tablet | Generic | $0.341 per tablet | $10.24 | -8% |
| Dexmethylphenidate 2.5 mg tablet | Generic | $0.190 per tablet | $5.70 | -0.8% |
| Dexmethylphenidate 5 mg tablet | Generic | $0.270 per tablet | $8.10 | +2% |
| Dexmethylphenidate ER 10 mg capsule | Generic | $1.45 per capsule | $43.56 | +4% |
| Dexmethylphenidate ER 15 mg capsule | Generic | $0.798 per capsule | $23.94 | -8% |
| Dexmethylphenidate ER 20 mg capsule | Generic | $1.69 per capsule | $50.77 | +5% |
| Dexmethylphenidate ER 25 mg capsule | Generic | $1.76 per capsule | $52.74 | +4% |
| Dexmethylphenidate ER 30 mg capsule | Generic | $1.56 per capsule | $46.78 | -20% |
| Dexmethylphenidate ER 35 mg capsule | Generic | $2.07 per capsule | $62.15 | -14% |
| Dexmethylphenidate ER 40 mg capsule | Generic | $1.66 per capsule | $49.70 | +8% |
| Dexmethylphenidate ER 5 mg capsule | Generic | $1.01 per capsule | $30.41 | -13% |
| Focalin 10 mg tablet | Brand | $1.33 per tablet | $39.88 | no change |
| Focalin 2.5 mg tablet | Brand | $0.650 per tablet | $19.50 | +0.3% |
| Focalin 5 mg tablet | Brand | $0.923 per tablet | $27.70 | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dexmethylphenidate been recalled?
The FDA's Enforcement Report lists 2 recalls naming dexmethylphenidate since 2015: 0 Class I (the most serious), 0 Class II, 2 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 1, 2026 | Class III | Sandoz Inc | Labeling: Incorrect or Missing Lot and/or Exp Date |
| July 28, 2015 | Class III | Novartis Pharmaceuticals Corp. | Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dexmethylphenidate label say about other medicines?
The dexmethylphenidate label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methylphenidate | contraindications | CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of Focalin. |
| Risperidone | drug interactions | Clinical impact; Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). |
Source: FDA drug label (Focalin), Sandoz Inc, effective May 30, 2024 (SPL set 2016f5c2-95d2-4655-af65-c588c2bf5e6d), via openFDA; the full label on DailyMed
What do FAERS reports show for dexmethylphenidate?
The FDA Adverse Event Reporting System holds 4,207 reports that list dexmethylphenidate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 400 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dexmethylphenidate?
9 other medicines are given the same way (oral) and in the same FDA class as dexmethylphenidate or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Amphetamine and dextroamphetamine | ADHD | 25 labelers | $0.233 per tablet 10 mg tablet | In shortage |
| Lisdexamfetamine | ADHD | 19 labelers | $2.44 per capsule 20 mg capsule | In shortage |
| Amphetamine | ADHD | 13 labelers | $0.449 per tablet 10 mg tablet | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
| Methamphetamine | ADHD | 3 labelers | $5.10 per tablet 5 mg tablet | No current entry |
| Atomoxetine | ADHD | 20 labelers | $0.442 per capsule 40 mg capsule | No current entry |
| Guanfacine | ADHD | 37 labelers | $0.147 per tablet 1 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as dexmethylphenidate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dexmethylphenidate compare with medicines for the same use?
4 side-by-side pages set dexmethylphenidate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dexmethylphenidate
- 9 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Dexmethylphenidate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other