Dexmethylphenidate
Dexmethylphenidate is a central nervous system (CNS) stimulant used to treat attention deficit hyperactivity disorder (ADHD), available as tablets and extended-release capsules.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 42 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Dexmethylphenidate (Focalin, Focalin XR) is a stimulant for ADHD and a familiar first choice. It is the more active form of methylphenidate, blocking the reabsorption of dopamine and norepinephrine and boosting their release, and has been on the market since the late 1990s and available generically. It is generally well tolerated, and the side effects people notice most are a smaller appetite, trouble sleeping and headache. Its boxed warning is for abuse, misuse and addiction, and misusing it, especially by snorting or injecting, can cause overdose and death, so keep it locked up and never share it. Expect heart rate and blood pressure checks, plus height and weight in children, since stimulants can slow growth.
Clinical pearls
- Never combine it with an MAOI antidepressant or take it within 14 days of stopping one, because blood pressure can spike dangerously.
- Extended-release capsules can be opened onto applesauce and eaten right away, but never crush or chew the beads.
- Take the capsule in the morning and space tablet doses at least 4 hours apart, which helps protect sleep.
- Before surgery, tell the anesthesia team you take it, since the capsules are avoided on days certain inhaled anesthetics are used.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Dexmethylphenidate has a high potential for abuse and misuse, which can lead to addiction. Misuse of stimulants can cause overdose and death. The risk is higher with larger doses or with unapproved methods such as snorting or injecting.
Your prescriber should check your risk before starting and keep watching for signs of misuse or addiction during treatment. Store the medicine safely and dispose of any unused medicine properly.
Patient information guide A plain-language walkthrough of Dexmethylphenidate, written from its FDA label.
What Dexmethylphenidate is used for
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Dexmethylphenidate is used for one condition across its products.
- ADHD: dexmethylphenidate tablets and Focalin tablets.
- ADHD: dexmethylphenidate extended-release capsules and Focalin XR (not recommended under age 6).
How Dexmethylphenidate works
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Dexmethylphenidate is a CNS stimulant and the more active form of methylphenidate. It blocks the reuptake of norepinephrine and dopamine into nerve cells and increases their release. How this helps ADHD is not known.
Dexmethylphenidate dosage
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Dosing differs by product, so follow your prescriber and label.
- Tablets (dexmethylphenidate and Focalin): taken by mouth twice a day, at least 4 hours apart, with or without food.
- Extended-release capsules (dexmethylphenidate and Focalin XR): taken by mouth once a day in the morning. Swallow whole, or open and sprinkle on applesauce and eat right away. Do not crush, chew or divide.
- Doses are raised gradually and tailored to each person.
Dosing details from the FDA-approved label
From the Dexmethylphenidate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Patients new to methylphenidate - pediatric patients (extended-release capsules)
- Start with 5 mg orally once daily in the morning with or without food
- Titrate weekly in increments of 5 mg
- Maximum: 30 mg in pediatric patients
- Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce
- Patients new to methylphenidate - adult patients (extended-release capsules)
- Start with 10 mg orally once daily in the morning with or without food
- Titrate weekly in increments of 10 mg
- Maximum: 40 mg in adults
- Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce
- Patients currently on methylphenidate (extended-release capsules)
- Half the total daily dose of racemic methylphenidate
- Patients currently on dexmethylphenidate immediate-release tablets (extended-release capsules)
- Give the same daily dose of the extended-release capsules
- Patients new to methylphenidate (immediate-release tablets)
- Starting dose of 5 mg once daily (2.5 mg twice daily), administered orally twice daily, 4 hours apart with or without food
- Titrate weekly in increments of 2.5 to 5 mg
- Maximum: 20 mg/day (10 mg twice daily)
- Patients currently taking methylphenidate (immediate-release tablets)
- Initiate therapy with half (1/2) the current total daily dose of methylphenidate
- Maximum: 20 mg/day (10 mg twice daily)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION N/A • Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2 ). • Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release capsules dosage is half (1/2) the current total daily dosage of methylphenidate ( 2.2 ). • Patients currently on dexmethylphenidate hydrochloride immediate-release tablets: Give the same daily dose of dexmethylphenidate hydrochloride extended-release capsules ( 2.2 ). • Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients ( 2.2 ). • Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults ( 2.2 ). • Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ( 2.3 ). 2.1 Pretreatment Screening Prior to treating patients with dexmethylphenidate hydrochloride extended-release capsules, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating dexmethylphenidate hydrochloride extended-release capsules [see Warnings and Precautions (5.10) ] . 2.2 Recommended Dosage Patients New to Methylphenidate The recommended starting dosage of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate are: • Pediatric patients: Start with 5 mg orally once daily in the morning with or without food. • Adult patients: Start with 10 mg orally once daily in the morning with or without food. Patients Currently on Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate. Patients currently using dexmethylphenidate hydrochloride immediate-release tablets may be given the same daily dose of dexmethylphenidate hydrochloride extended-release capsules.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dexmethylphenidate side effects
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Common side effects seen in studies include:
Common side effects
- Headache
- Decreased appetite
- Indigestion (dyspepsia)
- Anxiety
- Dry mouth (adults)
- Sore throat or throat pain (adults)
- Feeling jittery (adults)
- Trouble sleeping
When to get medical help
- Seek help right away for a painful or unusually long-lasting erection, or erections that happen too often.
- Call your doctor if you see or hear things that aren't there, have new paranoid or delusional thinking, or have manic symptoms.
- Call your doctor if your fingers or toes turn pale, blue or cold, or develop sores. This can be Raynaud’s phenomenon.
- Tell your doctor about new or worsening tics (sudden repeated movements or sounds).
- Get emergency help for swelling of the face, lips or throat, or signs of a serious allergic reaction.
- Report chest pain, a racing or pounding heartbeat, or fainting.
- Tell your doctor if you have eye pain or vision changes.
- Tell your doctor if you feel a strong urge to misuse the medicine or notice signs of misuse or addiction.
Get help right away for allergic reactions, a painful prolonged erection, hallucinations or manic symptoms, or color changes in fingers or toes.
Dexmethylphenidate warnings and precautions
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- Abuse, misuse and addiction can lead to overdose and death. Store securely and never share.
- Heart risks: avoid in serious heart disease. Blood pressure and heart rate usually rise a little and should be monitored.
- Mental health: can worsen psychosis or trigger mania, or cause new psychotic symptoms.
- Priapism: painful or prolonged erections need immediate care.
- Circulation: Raynaud’s phenomenon and finger or toe sores can occur.
- Growth: children may gain weight and height more slowly.
- Eyes and tics: glaucoma and eye pressure concerns, and new or worse tics.
Dexmethylphenidate interactions
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Tell your prescriber about every medicine you take. Key concerns:
- MAOIs: dangerous blood pressure spike. Never combine, or use within 14 days of stopping.
- Blood pressure medicines: may work less well.
- Halogenated anesthetics: sudden blood pressure and heart rate rise during surgery.
- Risperidone: higher chance of movement side effects when doses change.
Interactions listed in the FDA-approved label
From the Dexmethylphenidate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis; potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Concomitant use with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.
- Antihypertensive Drugs: Dexmethylphenidate extended-release capsules may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
- Halogenated Anesthetics: Concomitant use may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of dexmethylphenidate extended-release capsules in patients being treated with anesthetics on the day of surgery.
- Risperidone: Combined use of methylphenidate with risperidone when there is a change, increase or decrease, in dosage of either or both medications may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.
Read the label’s full interactions text
7 DRUG INTERACTIONS N/A • Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically Important Drug Interactions With Dexmethylphenidate Hydrochloride Extended-Release Capsules Table 5 presents clinically important drug interactions with dexmethylphenidate hydrochloride extended-release capsules. Table 5: Clinically Important Drug Interactions With Dexmethylphenidate Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [ see Contraindications (4) ] . Intervention Concomitant use of dexmethylphenidate hydrochloride extended-release capsules with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Dexmethylphenidate hydrochloride extended-release capsules may decrease the effectiveness of drugs used to treat hypertension [ see Warnings and Precautions (5.3) ] . Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical impact Concomitant use of halogenated anesthetics and dexmethylphenidate hydrochloride extended-release capsules may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of dexmethylphenidate hydrochloride extended-release capsules in patients being treated with anesthetics on the day of surgery. Risperidone 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) Intervention Monitor for signs of EPS
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dexmethylphenidate
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- Allergy to methylphenidate or any ingredient.
- Current or recent MAOI use.
- Heart disease or family history of sudden death.
- Psychosis, bipolar disorder, depression or family history of suicide.
- Tics or Tourette’s syndrome.
- Glaucoma or high eye pressure.
- Children: growth monitoring, and extended-release capsules not recommended under 6.
- Pregnancy or breastfeeding: discuss with your doctor.
Dexmethylphenidate overdose
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Too much stimulant can cause a fast or irregular heartbeat, blood pressure changes, agitation, confusion, hallucinations, seizures, dangerously high body temperature and muscle breakdown. Call the Poison Help line at 1-800-222-1222 or seek emergency care.
What Dexmethylphenidate does in the body
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Dexmethylphenidate is the more active form of methylphenidate. It blocks reuptake of norepinephrine and dopamine and increases their release outside the nerve cell. At the maximum recommended daily dose of the extended-release form, it does not meaningfully prolong the QTc interval (a heart rhythm measure).
How your body processes Dexmethylphenidate
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The extended-release capsule gives two peaks about 4 hours apart. The first comes in about 1.5 hours. The half-life is about 3 hours in adults and 2 to 3 hours in children. The body breaks it down mainly into an inactive metabolite, which is cleared mostly in urine. Only about 22% to 25% reaches the bloodstream because of first-pass metabolism.
How to store Dexmethylphenidate
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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dexmethylphenidate
85 supplements and herbal products have documented interactions with Dexmethylphenidate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 64
- Minor · 15
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Dexmethylphenidate: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dexmethylphenidate — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take it?
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What side effects should I expect?
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Can I take it with my other medicines?
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Is there a risk of addiction?
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What about pregnancy or children?
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Is Dexmethylphenidate available over the counter?
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Is Dexmethylphenidate a controlled substance?
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When was Dexmethylphenidate first available?
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Who makes Dexmethylphenidate?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dexmethylphenidate on HelloPharmacist
Dexmethylphenidate forms and strengths (how it comes)
Dexmethylphenidate is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Extended-release capsule
How this form is used
- Dexmethylphenidate Hydrochloride extended-release capsules are used to treat ADHD.
- Focalin XR is used to treat ADHD.
- Dexmethylphenidate extended-release capsules and Focalin XR are not recommended in children younger than 6 years.
- Dexmethylphenidate Hydrochloride extended-release capsules are taken once daily in the morning.
- Focalin XR can be swallowed whole or opened and the contents sprinkled on applesauce.
- Dexmethylphenidate Hydrochloride extended-release capsules and their contents should not be crushed, chewed or divided.
- Focalin XR may be taken with or without food.
Tablet
How this form is used
- Dexmethylphenidate Hydrochloride tablets are used to treat ADHD.
- Focalin tablets are used to treat ADHD.
- Dexmethylphenidate Hydrochloride tablets are taken twice daily, at least 4 hours apart, with or without food.
- Focalin tablets are taken twice daily, at least 4 hours apart.
- If side effects occur or there is no improvement after a month of dose adjustment, Focalin may be reduced or stopped by the prescriber.
Capsule
Show 1 more strength Show fewer strengths
Dexmethylphenidate on the U.S. market: products, makers and brands
How Dexmethylphenidate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
15 companies list 110 Dexmethylphenidate product records with the FDA, mostly as extended-release capsule, tablet, capsule; the earliest marketing or approval year on record is 1998. Brand names on the directory include Focalin, Focalin XR; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Dexmethylphenidate is used (Medicaid data)
A general measure of how commonly Dexmethylphenidate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dexmethylphenidate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dexmethylphenidate prescribed? Of the 1,601 medications we measure, Dexmethylphenidate ranks #116 by Medicaid prescriptions — more than 93% of them.
Utilization by Dexmethylphenidate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule Most dispensed
Summed across the 8 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899439
24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule
Summed across the 8 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899461
24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule
Summed across the 8 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899485
dexmethylphenidate hydrochloride 5 MG Oral Tablet
Summed across the 7 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899518
dexmethylphenidate hydrochloride 10 MG Oral Tablet
Summed across the 7 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899548
24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule
Summed across the 9 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899511
24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule
Summed across the 9 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899495
24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule
Summed across the 9 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1101926
dexmethylphenidate hydrochloride 2.5 MG Oral Tablet
Summed across the 5 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 899557
24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule
Summed across the 6 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1006608
24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule
Summed across the 6 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1101932
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dexmethylphenidate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 82 of 235 listed Dexmethylphenidate NDCs with Medicaid activity.
Compare Dexmethylphenidate products
A representative set of FDA-listed product records for Dexmethylphenidate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release capsule | ||||
| 5 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 10 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 15 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 20 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 25 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 30 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 35 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 5 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 15 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 35 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 35 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 30 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 35 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 35 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 10 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 15 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 20 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 25 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 30 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 35 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 40 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 5 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 10 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 15 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 20 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 25 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 30 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 35 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 40 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 5 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 5 mg | Oral | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 10 mg | Oral | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
| 15 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 15 mg | Oral | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
| 20 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 20 mg | Oral | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
| 25 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 30 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 35 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 40 mg | Oral | Sandoz Inc | NDA | View NDC → |
| 5 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 35 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 2.5 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 5 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 10 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
Showing 91 of 110 products — FDA National Drug Code Directory. See every product, package size and price: browse all 110 Dexmethylphenidate NDCs →
Dexmethylphenidate side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dexmethylphenidate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dexmethylphenidate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dexmethylphenidate FDA approval history
How Dexmethylphenidate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dexmethylphenidate recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Dexmethylphenidate recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- 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 Lots: Lot VA0099422; Exp. Date June 30, 2028 FDA record D-0608-2026 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 352372 2 dose forms · 11 strengths
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Dose form (SCDF) Extended Release Oral Capsule RxCUI 577227In current FDA listingsClinical drug / strength (SCD) 24 HR dexmethylphenidate hydrochloride 10 MGRxCUI 89943924 HR dexmethylphenidate hydrochloride 15 MGRxCUI 89946124 HR dexmethylphenidate hydrochloride 20 MGRxCUI 89948524 HR dexmethylphenidate hydrochloride 25 MGRxCUI 110192624 HR dexmethylphenidate hydrochloride 30 MGRxCUI 89949524 HR dexmethylphenidate hydrochloride 35 MGRxCUI 110193224 HR dexmethylphenidate hydrochloride 40 MGRxCUI 100660824 HR dexmethylphenidate hydrochloride 5 MGRxCUI 899511 -
Dose form (SCDF) Oral Tablet RxCUI 378713In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 899548hydrochloride 2.5 MGRxCUI 899557hydrochloride 5 MGRxCUI 899518
Look up RxCUI 352372 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dexmethylphenidate supply and shortage status
Whether Dexmethylphenidate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Dexmethylphenidate costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule, Extended Release · Oral | 5 mg | $4.70 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 10 mg | $4.76 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 20 mg | $4.91 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 15 mg | $4.91 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 30 mg | $4.75 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 25 mg | $5.13 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 35 mg | $5.43 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 40 mg | $5.41 per capsule | NDC details & price history |
| Tablet · Oral | 5 mg | $0.270 per tablet | NDC details & price history |
| Tablet · Oral | 10 mg | $0.341 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Dexmethylphenidate brand names
Dexmethylphenidate is sold under 2 brand names in the FDA directory — Focalin, Focalin XR. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dexmethylphenidate: manufacturers and labelers
15 companies list Dexmethylphenidate products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Sandoz Inc, Camber Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dexmethylphenidate drug class (RxNorm)
Dexmethylphenidate belongs to the Central Nervous System Stimulant class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dexmethylphenidate page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sandoz Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →