Prescription medicine
Methylphenidate Brand names: Metadate, Relexxii, Ritalin, Jornay, Quillivant
Methylphenidate (Ritalin) is a prescription medicine with an FDA approval on record since 1955. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $0.158 per methylphenidate 10 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.43 per mL (Quillivant XR 25 mg/5 mL suspension).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the methylphenidate FDA label on DailyMed (effective July 31, 2026, Lannett Company, LLC); the NDA 10187 record on Drugs@FDA; every methylphenidate label on DailyMed.
Highlights of the record
FDA label of July 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ABUSE, MISUSE, AND ADDICTION.
Methylphenidate HCl Extended-Release Capsules CD 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 Methylphenidate HCl Extended-Release Capsules CD, 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 Methylphenidate HCl Extended-Release Capsules CD, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of Methylphenidate HCl Extended-Release Capsules CD, and proper disposal of any unused drug. Throughout Methylphenidate HCl Extended-Release Capsules CD 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. Methylphenidate HCl Extended-Release Capsules CD has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. […]
Used for
From the label: indications and usageMethylphenidate HCl Extended-Release Capsules CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.
Forms and strengths
- 2.5 mg
- 5 mg
- 8.6 mg
- 10 mg
- 15 mg
- 17.3 mg
- 18 mg
- 20 mg
- 25.9 mg
- 27 mg
- 30 mg
- 36 mg
Extended-release capsule; extended-release tablet; tablet; solution; chewable tablet.
On the market
- Earliest approval on file
- December 5, 1955 Ritalin, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 74 first December 23, 1977; 46 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 45 of which 31 under generic applications, 11 under brand applications, repackagers included
- Last listed patent
- November 19, 2038 Adhansia XR capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.158 per tablet Methylphenidate 10 mg tablet
- Shortage (FDA)
- 15 of 38 presentations limited or unavailable updated October 1, 2026
- Recalls by its makers (FDA)
- 55 since 2011 0 Class I among all firms' recalls; latest June 17, 2024
- FAERS reports
- 73,102 through July 30, 2026
What is methylphenidate used for?
From the label: indications and usageMethylphenidate HCl Extended-Release Capsules CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. […]
Conditions named in the indications of methylphenidate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (methylphenidate hydrochloride CD), Lannett Company, LLC, effective July 31, 2026 (SPL set e45c75dc-d381-475b-b649-a871c8a36e60), via openFDA; the full label on DailyMed
What does the patient leaflet for methylphenidate 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 Methylphenidate HCl Extended-Release Capsules CD?Methylphenidate HCl Extended-Release Capsules CD may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate HCl Extended-Release Capsules CD has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Methylphenidate HCl Extended-Release Capsules CD, other methylphenidate medicines, and amphetamine medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Methylphenidate HCl Extended-Release Capsules CD or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with Methylphenidate HCl Extended-Release Capsules CD and will monitor your child during treatment. Methylphenidate HCl Extended-Release Capsules CD may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Methylphenidate HCl Extended-Release Capsules CD to anyone else because it may cause death or harm them. Keep Methylphenidate HCl Extended-Release Capsules CD in a safe place and properly dispose of any unused medicine. See “ How should I store Methylphenidate HCl Extended-Release Capsules CD? ” for more information. Tell your healthcare provider if your child has 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 your child carefully for heart problems before starting treatment with Methylphenidate HCl Extended-Release Capsules CD. […]
From the patient leaflet: What should be avoided during treatment with Methylphenidate HCl Extended-Release Capsules CD?Avoid drinking alcohol during treatment with Methylphenidate HCl Extended-Release Capsules CD. This may cause a faster release of the Methylphenidate HCl Extended-Release Capsules CD medicine.
From the patient leaflet: How should I store Methylphenidate HCl Extended-Release Capsules CD?Store Methylphenidate HCl Extended-Release Capsules CD at room temperature between 68°F to 77°F (20°C to 25°C). Store Methylphenidate HCl Extended-Release Capsules CD in a safe place, like a locked cabinet. Protect from light and moisture. Dispose of remaining, unused, or expired Methylphenidate HCl Extended-Release Capsules CD 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 Methylphenidate HCl Extended-Release Capsules CD 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 Methylphenidate HCl Extended-Release Capsules CD in the household trash. […]
Source: FDA drug label (methylphenidate hydrochloride CD), Lannett Company, LLC, effective July 31, 2026 (SPL set e45c75dc-d381-475b-b649-a871c8a36e60), via openFDA; the full label on DailyMed
Is there a generic for methylphenidate (Ritalin)?
The FDA approved the first generic methylphenidate on December 23, 1977. 74 generic applications are approved; 46 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists methylphenidate from 31 labelers under a generic (ANDA) application and from 11 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ritalin LA capsules; a patent listed only for Adhansia XR capsules runs to November 19, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1955 earliest approval on file
- 1977 first generic approved
- 2038 last listed patent
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for methylphenidate (Ritalin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.158 per Methylphenidate 10 mg tablet, down 14% from $0.184 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.
- Methylphenidate 5 mg tablet (generic)
- Quillivant XR 25 mg/5 mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Methylphenidate 10 mg chewable tablet | Generic | $2.95 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $88.61 | +2% |
| Methylphenidate 10 mg tablet | Generic | $0.158 per tablet | $4.74 | -14% |
| Methylphenidate 10 mg/5 mL solution | Generic | $0.120 per mL | n/a | -0.6% |
| Methylphenidate 10 mg/9 hr patch | Generic | $6.66 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -24% |
| Methylphenidate 15 mg/9 hr patch | Generic | $6.63 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -29% |
| Methylphenidate 2.5 mg chewable tablet | Generic | $1.30 per tablet | $38.97 | +19% |
| Methylphenidate 20 mg tablet | Generic | $0.201 per tablet | $6.04 | -10% |
| Methylphenidate 20 mg/9 hr patch | Generic | $6.61 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -36% |
| Methylphenidate 30 mg/9 hr patch | Generic | $7.25 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -24% |
| Methylphenidate 5 mg chewable tablet | Generic | $2.01 per tablet | $60.28 | +3% |
| Methylphenidate 5 mg tablet | Generic | $0.127 per tablet | $3.80 | -6% |
| Methylphenidate 5 mg/5 mL solution | Generic | $0.0782 per mL | n/a | +5% |
| Methylphenidate cd 10 mg capsule | Generic | $1.40 per capsule | $42.03 | +14% |
| Methylphenidate cd 20 mg capsule | Generic | $1.39 per capsule | $41.63 | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is methylphenidate in shortage?
The FDA Drug Shortage Database lists 15 of 38 methylphenidate presentations as limited or unavailable (updated October 1, 2026); the first entry was posted on July 26, 2023. 23 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) | Janssen Pharmaceuticals | Current | September 17, 2026 |
| Concerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01) | Janssen Pharmaceuticals | Current | September 17, 2026 |
| Concerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01) | Janssen Pharmaceuticals | Current | September 17, 2026 |
| Concerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01) | Janssen Pharmaceuticals | Current | September 17, 2026 |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 13811-706-10) | Trigen Laboratories, LLC | Current | October 1, 2026 |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 57664-606-88) | Sun Pharmaceutical Industries, Inc. | Current | September 18, 2026 |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 62037-725-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 62175-310-37) | Lannett Company, Inc. | Current | October 1, 2026 |
Every methylphenidate presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has methylphenidate been recalled?
The FDA's Enforcement Report lists 55 recalls naming methylphenidate since 2011: 0 Class I (the most serious), 50 Class II, 5 Class III; 10 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 17, 2024 | Class II | Trigen Laboratories | Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications. |
| July 13, 2023 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Foreign Substance: Metal embedded in a tablet. |
| March 10, 2023 | Class II | Noven Pharmaceuticals Inc | Defective Delivery System: Out of specification for shear. |
| November 16, 2022 | Class II | Noven Pharmaceuticals Inc | Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the … |
| June 24, 2022 | Class II | Noven Pharmaceuticals Inc | Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer. |
| May 6, 2022 | Class II | Noven Pharmaceuticals Inc | Defective Delivery System: customer complaints exceeded respective action limits. |
| February 7, 2022 | Class II | RISING PHARMACEUTICALS | Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet … |
| May 20, 2021 | Class II | Noven Pharmaceuticals Inc | Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the methylphenidate label say about other medicines?
The methylphenidate label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 13 other medicines name methylphenidate. 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 |
|---|---|---|
| Risperidone | drug interactions | Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms. |
Other labels that name methylphenidate
Source: FDA drug label (methylphenidate hydrochloride CD), Lannett Company, LLC, effective July 31, 2026 (SPL set e45c75dc-d381-475b-b649-a871c8a36e60), via openFDA; the full label on DailyMed
What do FAERS reports show for methylphenidate?
The FDA Adverse Event Reporting System holds 73,102 reports that list methylphenidate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,733 are coded as a death and 12,315 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 methylphenidate?
10 other medicines are given the same way (oral) and in the same FDA class as methylphenidate 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 |
|---|---|---|---|---|
| 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 |
| Dexmethylphenidate | ADHD | 13 labelers | $1.45 per capsule 10 mg capsule | No current entry |
| 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 |
| Dexmethylphenidate and serdexmethylphenidate | ADHD | none listed | $14.40 per capsule 26.1 mg-5.2 mg capsule | 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 |
Every medicine labeled for the same conditions as methylphenidate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does methylphenidate compare with medicines for the same use?
7 side-by-side pages set methylphenidate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to methylphenidate
- 10 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Methylphenidate side effects
- the label's list beside FAERS reports
- Methylphenidate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other