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METHYLPHENIDATE HYDROCHLORIDE
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Central Nervous System Stimulant [EPC] | EPC | All 93 members |
| Central Nervous System Stimulation [PE] | PE | All 95 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208737-001 | METHYLPHENIDATE HYDROCHLORIDE | TABLET | METHYLPHENIDATE HYDROCHLORIDE | Prescription | AB | ||
| 208737-002 | METHYLPHENIDATE HYDROCHLORIDE | TABLET | METHYLPHENIDATE HYDROCHLORIDE | Prescription | AB | ||
| 208737-003 | METHYLPHENIDATE HYDROCHLORIDE | TABLET | METHYLPHENIDATE HYDROCHLORIDE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 2 | Labeling | Approved | April 1, 2024 | Standard |
| Supplement | 1 | Labeling | Approved | December 16, 2022 | Standard |
| Original application | 1 | Approved | February 1, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260102). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: ABUSE, MISUSE, AND ADDICTION WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride tablets have 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 hydrochloride tablets, 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 hydrochloride tablets, 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 methylphenidate hydrochloride tablets 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 hydrochloride tablets have 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 hydrochloride tablets, can result in overdose and death (5.1 , 9.2 , 10) : Before prescribing methylphenidate hydrochloride tablets, 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Recent Major Changes
openFDA Drug LabelingBoxed Warning 10/2023 Dosage and Administration (2.1) 10/2023 Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10) 10/2023 Boxed Warning 10/2023 Dosage and Administration ( 2.1 ) 10/2023 Warnings and Precautions ( 5.1 , 5.2 , 5.8 , 5.9 , 5.10 ) 10/2023
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Methylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1 ).
Dosage and Administration
openFDA Drug Labeling2. DOSAGE AND ADMINISTRATION Methylphenidate Hydrochloride Tablets, USP (2.2) : Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10- mg increments. Dosages above 60 mg/day are not recommended. Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. 2.1 Pretreatment Screening Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including methylphenidate hydrochloride tablets, assess for the presence of cardiac disease (i.e., perform a careful history, including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5.2)] . Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for methylphenidate hydrochloride tablets use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)]. 2.2 General Dosing Information Methylphenidate Hydrochloride Tablets Pediatric Patients 6 years and Older: Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5- to 10- mg weekly. Daily dosage above 60 mg is not recommended. Adults: Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m. Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets, and adjust dosage as needed. 2.3 Dose Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Methylphenidate Hydrochloride Tablets, USP 5 mg, light purple, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "228" on one side and S5 on the other side. 10 mg, light green, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "229" on one side and S and 10 on either side of the score line on the other side. 20 mg, light peach, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "230" on one side and S and 20 on either side of the score line on the other side. Tablets: 5 mg, 10 mg, and 20 mg (3)
Contraindications
openFDA Drug Labeling2.3 Dosage Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
4 CONTRAINDICATIONS • Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6 )] . • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )] . • Known hypersensitivity to methylphenidate or other product components of methylphenidate hydrochloride tablets ( 4 ). • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ).
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease (5.2). Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse (5.3). Psychiatric Adverse Reactions : Prior to initiating methylphenidate hydrochloride tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride tablets (5.4). Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention (5.5). Peripheral Vasculopathy, Including Raynaud’s Phenomenon : Careful observation for digital changes is necessary during methylphenidate hydrochloride tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy (5.6). Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted (5.7). Acute Angle Closure Glaucoma: Methylphenidate hydrochloride tablets -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist (5.8). Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe methylphenidate hydrochloride tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma (5.9). Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating methylphenidate hydrochloride tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate (5.10). 5.1 Abuse, Misuse, and Addiction Methylphenidate hydrochloride tablets have a high potential for abuse and misuse. The use of methylphenidate hydrochloride tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate hydrochloride tablets can be diverted for nonmedical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2) ]. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride tablets, 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 hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store methylphenidate hydrochloride tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride tablets to anyone else. Throughout methylphenidate hydrochloride tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 5.2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosage. Avoid methylphenidate hydrochloride tablets use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 ) ] • Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride tablets [see Contraindications ( 4 )] • Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] • Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Priapism [see Warnings and Precautions ( 5.5 )] • Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see Warnings and Precautions ( 5.6 )] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.7 )] • Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.10 )] The following adverse reactions associated with the use of methylphenidate hydrochloride tablets and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse Reactions Reported with Methylphenidate Hydrochloride Tablets Infections and Infestations: nasopharyngitis Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia, anemia Immune System Disorders: hypersensitivity reactions, including angioedema, and anaphylaxis Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, depression Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs Eye Disorders: blurred vision, difficulties in visual accommodation Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris Respiratory, Thoracic, and Mediastinal Disorders: cough Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis, trismus Investigations: weight loss (adult ADHD patients) Vascular Disorders: peripheral coldness, Raynaud's phenomenon Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions not listed for methylphenidate hydrochloride tablets that have been reported with other methylphenidate-containing products. Blood and Lymphatic Disorders: pancytopenia Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas Psychiatric Disorders: affect lability, mania, disorientation, and libido changes Nervous System Disorders: migraine, motor and verbal tics Eye Disorders: diplopia, increased intraocular pressure, mydriasis Cardiac Disorders: sudden cardiac death, myocardial infarc …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7.1). Halogenated Anesthetics: Avoid use of methylphenidate hydrochloride tablets on the day of surgery if halogenated anesthetics will be used (7.1). 7.1 Clinically Important Drug Interactions with Methylphenidate Hydrochloride Table 1 presents clinically important drug interactions with methylphenidate hydrochloride tablets Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride 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 methylphenidate hydrochloride with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Methylphenidate hydrochloride 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. Examples Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and methylphenidate hydrochloride may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of methylphenidate hydrochloride in patients being treated with anesthetics on the day of surgery. Examples halothane, isoflurane, enflurane, desflurane, sevoflurane 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
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylphenidate hydrochloride tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as Methylphenidate hydrochloride tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m 2 basis). 8.2 Lactation Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infa …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known.
Description
openFDA Drug Labeling11 DESCRIPTION Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, USP a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Each tablet contains 5 mg, 10 mg, or 20 mg of methylphenidate hydrochloride, USP. Inactive ingredients include: lactose monohydrate, magnesium stearate, polyethylene glycol 8000, and talc. In addition, the 5 mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, the 10 mg tablet contains FD&C blue No. 2 aluminum lake and D&C yellow No. 10 aluminum lake and the 20 mg tablet contains FD&C yellow No. 6 aluminum lake. Structure
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Hydrochloride Tablets, USP are available as follows 5 mg Tablets - light yellow colored, round, flat face tablets with "n above 573" debossed on one side and plain on the other side, supplied as: Bottles of 30 .........................................NDC 43386-573-03 Bottles of 100.......................................NDC 43386-573-01 Bottles of 500 .......................................NDC 43386-573-05 10 mg Tablets - white to off white colored, round, flat face tablets with "n above 574" debossed on one side and bisected line debossed on the other side, supplied as: Bottles of 30 ....................................... NDC 43386-574-03 Bottles of 100.......................................NDC 43386-574-01 Bottles of 500 .......................................NDC 43386-574-05 20 mg Tablets - light yellow colored, round biconvex tablets with "n above 575" debossed on one side and bisect line debossed on the other side, supplied as: Bottles of 30 .........................................NDC 43386-575-03 Bottles of 100.......................................NDC 43386-575-01 Bottles of 500 .......................................NDC 43386-575-05 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15oC and 30oC (59oF and 86oF) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride tablets by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard methylphenidate hydrochloride tablets in the household trash.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: METHYLPHENIDATE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | August 2, 2023 | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Foreign Substance: Metal embedded in a tablet. | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 16729-478-01 | 16729-478 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-478-01) | December 23, 2020 |
| 16729-479-01 | 16729-479 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-479-01) | December 17, 2020 |
| 16729-480-01 | 16729-480 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-480-01) | December 17, 2020 |
| 68084-805-21 | 68084-805 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-805-21) / 1 TABLET in 1 BLISTER PACK (68084-805-11) | September 30, 2014 |
| 68084-823-21 | 68084-823 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-823-21) / 1 TABLET in 1 BLISTER PACK (68084-823-11) | September 30, 2014 |
| 0115-1800-01 | 0115-1800 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1800-01) | April 7, 2014 |
| 0115-1801-01 | 0115-1801 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1801-01) | April 7, 2014 |
| 0115-1802-01 | 0115-1802 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1802-01) | April 7, 2014 |
| 67877-616-01 | 67877-616 | Ascend Laboratories, LLC | 100 TABLET in 1 BOTTLE (67877-616-01) | October 6, 2019 |
| 67877-616-33 | 67877-616 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-616-33) / 1 TABLET in 1 BLISTER PACK | October 6, 2019 |
| 67877-617-01 | 67877-617 | Ascend Laboratories, LLC | 100 TABLET in 1 BOTTLE (67877-617-01) | October 6, 2019 |
| 67877-617-33 | 67877-617 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-617-33) / 1 TABLET in 1 BLISTER PACK | October 6, 2019 |
| 67877-618-01 | 67877-618 | Ascend Laboratories, LLC | 100 TABLET in 1 BOTTLE (67877-618-01) | October 6, 2019 |
| 67877-618-33 | 67877-618 | Ascend Laboratories, LLC | 10 BLISTER PACK in 1 CARTON (67877-618-33) / 1 TABLET in 1 BLISTER PACK | October 6, 2019 |
| 13107-380-01 | 13107-380 | Aurolife Pharma, LLC | 100 TABLET in 1 BOTTLE (13107-380-01) | April 11, 2017 |
| 13107-381-01 | 13107-381 | Aurolife Pharma, LLC | 100 TABLET in 1 BOTTLE (13107-381-01) | April 11, 2017 |
| 13107-382-01 | 13107-382 | Aurolife Pharma, LLC | 100 TABLET in 1 BOTTLE (13107-382-01) | April 11, 2017 |
| 63629-1172-1 | 63629-1172 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-1172-1) | August 16, 2013 |
| 71335-1219-1 | 71335-1219 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1219-1) | October 31, 2024 |
| 71335-1219-2 | 71335-1219 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1219-2) | October 31, 2024 |
| 71335-1219-3 | 71335-1219 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1219-3) | April 24, 2019 |
| 71335-1219-4 | 71335-1219 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1219-4) | April 24, 2019 |
| 71335-1219-5 | 71335-1219 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1219-5) | October 31, 2024 |
| 71335-2968-1 | 71335-2968 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2968-1) | November 11, 2025 |
| 72162-1636-1 | 72162-1636 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1636-1) | August 16, 2013 |
| 72162-2019-1 | 72162-2019 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2019-1) | April 3, 2024 |
| 72162-2019-6 | 72162-2019 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (72162-2019-6) | April 3, 2024 |
| 72162-2086-1 | 72162-2086 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2086-1) | April 3, 2024 |
| 72162-2087-1 | 72162-2087 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2087-1) | April 3, 2024 |
| 72162-2428-1 | 72162-2428 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2428-1) | November 18, 2024 |
| 72162-2429-1 | 72162-2429 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2429-1) | November 18, 2024 |
| 72162-2430-1 | 72162-2430 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2430-1) | November 18, 2024 |
| 31722-173-01 | 31722-173 | Camber Pharmaceutical Inc | 100 TABLET in 1 BOTTLE (31722-173-01) | October 1, 2015 |
| 31722-173-05 | 31722-173 | Camber Pharmaceutical Inc | 500 TABLET in 1 BOTTLE (31722-173-05) | October 1, 2015 |
| 31722-174-01 | 31722-174 | Camber Pharmaceutical Inc | 100 TABLET in 1 BOTTLE (31722-174-01) | October 1, 2015 |
| 31722-174-05 | 31722-174 | Camber Pharmaceutical Inc | 500 TABLET in 1 BOTTLE (31722-174-05) | October 1, 2015 |
| 31722-175-01 | 31722-175 | Camber Pharmaceutical Inc | 100 TABLET in 1 BOTTLE (31722-175-01) | October 1, 2015 |
| 31722-175-05 | 31722-175 | Camber Pharmaceutical Inc | 500 TABLET in 1 BOTTLE (31722-175-05) | October 1, 2015 |
| 10702-100-01 | 10702-100 | KVK-TECH, INC. | 100 TABLET in 1 BOTTLE (10702-100-01) | May 11, 2017 |
| 10702-101-01 | 10702-101 | KVK-TECH, INC. | 100 TABLET in 1 BOTTLE (10702-101-01) | May 11, 2017 |
| 10702-102-01 | 10702-102 | KVK-TECH, INC. | 100 TABLET in 1 BOTTLE (10702-102-01) | May 11, 2017 |
| 43386-573-01 | 43386-573 | Lupin Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (43386-573-01) | January 20, 2016 |
| 43386-574-01 | 43386-574 | Lupin Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (43386-574-01) | January 20, 2016 |
| 43386-575-01 | 43386-575 | Lupin Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (43386-575-01) | January 20, 2016 |
| 75834-324-01 | 75834-324 | Nivagen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (75834-324-01) | April 16, 2024 |
| 75834-325-01 | 75834-325 | Nivagen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (75834-325-01) | April 16, 2024 |
| 75834-326-01 | 75834-326 | Nivagen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (75834-326-01) | April 16, 2024 |
| 43547-486-10 | 43547-486 | Solco Healthcare US,LLC | 100 TABLET in 1 BOTTLE (43547-486-10) | July 1, 2020 |
| 43547-487-10 | 43547-487 | Solco Healthcare US,LLC | 100 TABLET in 1 BOTTLE (43547-487-10) | July 1, 2020 |
| 43547-488-10 | 43547-488 | Solco Healthcare US,LLC | 100 TABLET in 1 BOTTLE (43547-488-10) | July 1, 2020 |
| 0406-1142-01 | 0406-1142 | SpecGx LLC | 100 TABLET in 1 BOTTLE (0406-1142-01) | November 27, 1998 |
| 0406-1142-10 | 0406-1142 | SpecGx LLC | 1000 TABLET in 1 BOTTLE (0406-1142-10) | November 27, 1998 |
| 0406-1144-01 | 0406-1144 | SpecGx LLC | 100 TABLET in 1 BOTTLE (0406-1144-01) | November 27, 1998 |
| 0406-1144-10 | 0406-1144 | SpecGx LLC | 1000 TABLET in 1 BOTTLE (0406-1144-10) | November 27, 1998 |
| 0406-1146-01 | 0406-1146 | SpecGx LLC | 100 TABLET in 1 BOTTLE (0406-1146-01) | November 27, 1998 |
| 0406-1146-10 | 0406-1146 | SpecGx LLC | 1000 TABLET in 1 BOTTLE (0406-1146-10) | November 27, 1998 |
| 57664-228-08 | 57664-228 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (57664-228-08) | August 16, 2013 |
| 57664-228-13 | 57664-228 | Sun Pharmaceutical Industries, Inc. | 500 TABLET in 1 BOTTLE (57664-228-13) | August 16, 2013 |
| 57664-228-18 | 57664-228 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (57664-228-18) | August 16, 2013 |
| 57664-228-83 | 57664-228 | Sun Pharmaceutical Industries, Inc. | 30 TABLET in 1 BOTTLE (57664-228-83) | August 16, 2013 |
| 57664-228-88 | 57664-228 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (57664-228-88) | August 16, 2013 |
| 57664-229-08 | 57664-229 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (57664-229-08) | August 16, 2013 |
| 57664-229-13 | 57664-229 | Sun Pharmaceutical Industries, Inc. | 500 TABLET in 1 BOTTLE (57664-229-13) | August 16, 2013 |
| 57664-229-18 | 57664-229 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (57664-229-18) | August 16, 2013 |
| 57664-229-83 | 57664-229 | Sun Pharmaceutical Industries, Inc. | 30 TABLET in 1 BOTTLE (57664-229-83) | August 16, 2013 |
| 57664-229-88 | 57664-229 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (57664-229-88) | August 16, 2013 |
| 57664-230-08 | 57664-230 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (57664-230-08) | August 16, 2013 |
| 57664-230-13 | 57664-230 | Sun Pharmaceutical Industries, Inc. | 500 TABLET in 1 BOTTLE (57664-230-13) | August 16, 2013 |
| 57664-230-18 | 57664-230 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (57664-230-18) | August 16, 2013 |
| 57664-230-83 | 57664-230 | Sun Pharmaceutical Industries, Inc. | 30 TABLET in 1 BOTTLE (57664-230-83) | August 16, 2013 |
| 57664-230-88 | 57664-230 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (57664-230-88) | August 16, 2013 |
| 72865-122-01 | 72865-122 | XLCare Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (72865-122-01) | February 26, 2020 |
| 72865-122-05 | 72865-122 | XLCare Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (72865-122-05) | February 26, 2020 |
| 72865-123-01 | 72865-123 | XLCare Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (72865-123-01) | February 26, 2020 |
| 72865-123-05 | 72865-123 | XLCare Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (72865-123-05) | February 26, 2020 |
| 72865-124-01 | 72865-124 | XLCare Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (72865-124-01) | February 26, 2020 |
| 72865-124-05 | 72865-124 | XLCare Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (72865-124-05) | February 26, 2020 |
| 16729-478 | 16729-478 | Accord Healthcare, Inc. | — | December 23, 2020 |
| 16729-479 | 16729-479 | Accord Healthcare, Inc. | — | December 17, 2020 |
| 16729-480 | 16729-480 | Accord Healthcare, Inc. | — | December 17, 2020 |
| 68084-805 | 68084-805 | American Health Packaging | — | September 30, 2014 |
| 68084-823 | 68084-823 | American Health Packaging | — | September 30, 2014 |
| 0115-1800 | 0115-1800 | Amneal Pharmaceuticals of New York LLC | — | April 7, 2014 |
| 0115-1801 | 0115-1801 | Amneal Pharmaceuticals of New York LLC | — | April 7, 2014 |
| 0115-1802 | 0115-1802 | Amneal Pharmaceuticals of New York LLC | — | April 7, 2014 |
| 67877-616 | 67877-616 | Ascend Laboratories, LLC | — | October 6, 2019 |
| 67877-617 | 67877-617 | Ascend Laboratories, LLC | — | October 6, 2019 |
| 67877-618 | 67877-618 | Ascend Laboratories, LLC | — | October 6, 2019 |
| 13107-380 | 13107-380 | Aurolife Pharma, LLC | — | April 11, 2017 |
| 13107-381 | 13107-381 | Aurolife Pharma, LLC | — | April 11, 2017 |
| 13107-382 | 13107-382 | Aurolife Pharma, LLC | — | April 11, 2017 |
| 63629-1172 | 63629-1172 | Bryant Ranch Prepack | — | August 16, 2013 |
| 71335-1219 | 71335-1219 | Bryant Ranch Prepack | — | October 1, 2015 |
| 71335-2968 | 71335-2968 | Bryant Ranch Prepack | — | April 16, 2024 |
| 72162-1636 | 72162-1636 | Bryant Ranch Prepack | — | August 16, 2013 |
| 72162-2019 | 72162-2019 | Bryant Ranch Prepack | — | April 7, 2014 |
| 72162-2086 | 72162-2086 | Bryant Ranch Prepack | — | April 7, 2014 |
| 72162-2087 | 72162-2087 | Bryant Ranch Prepack | — | April 7, 2014 |
| 72162-2428 | 72162-2428 | Bryant Ranch Prepack | — | April 16, 2024 |
| 72162-2429 | 72162-2429 | Bryant Ranch Prepack | — | April 16, 2024 |
| 72162-2430 | 72162-2430 | Bryant Ranch Prepack | — | April 16, 2024 |
| 31722-173 | 31722-173 | Camber Pharmaceutical Inc | — | October 1, 2015 |
| 31722-174 | 31722-174 | Camber Pharmaceutical Inc | — | October 1, 2015 |
| 31722-175 | 31722-175 | Camber Pharmaceutical Inc | — | October 1, 2015 |
| 10702-100 | 10702-100 | KVK-TECH, INC. | — | May 11, 2017 |
| 10702-101 | 10702-101 | KVK-TECH, INC. | — | May 11, 2017 |
| 10702-102 | 10702-102 | KVK-TECH, INC. | — | May 11, 2017 |
| 43386-573 | 43386-573 | Lupin Pharmaceuticals,Inc. | — | January 20, 2016 |
| 43386-574 | 43386-574 | Lupin Pharmaceuticals,Inc. | — | November 13, 2015 |
| 43386-575 | 43386-575 | Lupin Pharmaceuticals,Inc. | — | November 13, 2015 |
| 75834-324 | 75834-324 | Nivagen Pharmaceuticals, Inc. | — | April 16, 2024 |
| 75834-325 | 75834-325 | Nivagen Pharmaceuticals, Inc. | — | April 16, 2024 |
| 75834-326 | 75834-326 | Nivagen Pharmaceuticals, Inc. | — | April 16, 2024 |
| 43547-486 | 43547-486 | Solco Healthcare US,LLC | — | July 1, 2020 |
| 43547-487 | 43547-487 | Solco Healthcare US,LLC | — | July 1, 2020 |
| 43547-488 | 43547-488 | Solco Healthcare US,LLC | — | July 1, 2020 |
| 0406-1142 | 0406-1142 | SpecGx LLC | — | November 27, 1998 |
| 0406-1144 | 0406-1144 | SpecGx LLC | — | November 27, 1998 |
| 0406-1146 | 0406-1146 | SpecGx LLC | — | November 27, 1998 |
| 57664-228 | 57664-228 | Sun Pharmaceutical Industries, Inc. | — | August 16, 2013 |
| 57664-229 | 57664-229 | Sun Pharmaceutical Industries, Inc. | — | August 16, 2013 |
| 57664-230 | 57664-230 | Sun Pharmaceutical Industries, Inc. | — | August 16, 2013 |
| 72865-122 | 72865-122 | XLCare Pharmaceuticals Inc | — | February 26, 2020 |
| 72865-123 | 72865-123 | XLCare Pharmaceuticals Inc | — | February 26, 2020 |
| 72865-124 | 72865-124 | XLCare Pharmaceuticals Inc | — | February 26, 2020 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.