methylphenidate hydrochloride CD

Indications and Usage ( 1 ) 09/2025 Contraindications ( 4 ) 07/2026 Warnings and Precautions ( 5.7 ) 09/2025

1 INDICATIONS AND USAGE Methylphenidate 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 )] . Methylphenidate HCl Extended-Release Capsules CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. ( 1 ) 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 exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.7 , 8.4 )

2 DOSAGE AND ADMINISTRATION Prior to initiating Methylphenidate HCl Extended-Release Capsules CD treatment, assess each patient’s risk for ( 2.1 ): Abuse, misuse, and addiction ( 5.1 ) Presence of cardiac disease ( 5.2 ) Developing a manic episode ( 5.4 ) A family history of tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette syndrome ( 5.10 ) Take orally once daily in the morning, before breakfast. Swallow whole with the aid of liquids, or sprinkle contents onto a small amount of applesauce and give immediately. Do not crush or chew the capsule or capsule contents ( 2.1 ) Recommended starting dose is 20 mg once daily. Dosage may be increased 10-20 mg at weekly intervals; do not exceed 60 mg per day ( 2.2 ) 2.1 Pretreatment Screening Prior to treating patients with Methylphenidate HCl Extended-Release Capsules CD, assess: The risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 )] . For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . The risk for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression) [see Warnings and Precautions ( 5.4 )] . For a family history for tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions ( 5.10 )] . 2.2 Dosage Recommendations The recommended starting dose of Methylphenidate HCl Extended-Release Capsules CD is 20 mg once daily. Dosage may be adjusted in weekly 10 mg to 20 mg increments to the maximum recommended dose of 60 mg per day. Dosage should be individualized according to the needs and responses of the patient. 2.3 Administration Instructions Administer Methylphenidate HCl Extended-Release Capsules CD orally once daily in the morning, before breakfast. Swallow the capsule whole with the aid of liquids. Alternatively, open the capsule and sprinkle the contents onto a small amount (tablespoon) of applesauce and administer immediately. Do not store for future use. Drink fluids following the intake of the sprinkled capsule contents with applesauce. The capsules and the capsule contents must not be crushed or chewed. 2.4 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue Methylphenidate HCl Extended-Release Capsules CD. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue Methylphenidate HCl Extended-Release Capsules CD. 2.5 Switching from a Monoamine Oxidase Inhibitor Must wait at least 14 days after stopping a monoamine oxidase (MAO) inhibitor before starting Methylphenidate HCl Extended-Release Capsules CD [see Contraindications ( 4 ) and Drug Interactions ( 7 )] .

3 DOSAGE FORMS AND STRENGTHS Methylphenidate HCl Extended-Release Capsules CD extended-release capsules are available in the following dosage strengths (see Table 1): Table 1: Strengths and Identifying Characteristics of Methylphenidate HCl Extended-Release Capsules CD Strength Capsule Color (cap/body) Imprinting on Capsule Cap Imprinting on Capsule Body 10 mg green/white “LANNETT 4579” in white letters “10 mg” in black letters 20 mg blue/white “LANNETT 4580” in white letters “20 mg” in black letters 30 mg reddish-brown/white “LANNETT 4581” in white letters “30 mg” in black letters 40 mg yellow ivory/white “LANNETT 4582” in black letters “40 mg” in black letters 50 mg purple/white “LANNETT 4583” in white letters “50 mg” in black letters 60 mg white/white capsules “LANNETT 4584” in black letters “60 mg” in black letters Extended-release capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg ( 3 )

4 CONTRAINDICATIONS Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients with: Known hypersensitivity to methylphenidate or other component of Methylphenidate HCl Extended-Release Capsules CD. Angioedema has been reported in patients treated with Methylphenidate HCl Extended-Release Capsules CD. Anaphylactic reactions have been reported in patients treated with other methylphenidate products [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 crisis [see Drug Interactions ( 7 )] . Methylphenidate HCl Extended-Release Capsules CD contains sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received a methylphenidate product. Methylphenidate HCl Extended-Release Capsules CD is contraindicated in: Known hypersensitivity to methylphenidate or other components of Methylphenidate HCl Extended-Release Capsules CD ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ) Use in patients with patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency ( 4 ) Patients with pheochromocytoma or a history of pheochromocytoma ( 4 )

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to Methylphenidate and Other Component of Methylphenidate HCl Extended-Release Capsules CD [see Contraindications ( 4 )] Hypertensive Crisis when Used Concomitantly with MAOIs [see Contraindications (4) and Drug Interactions ( 7 )] 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 most common adverse reactions (≥ 5% and twice the rate of placebo) were anorexia and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical trials experience with Methylphenidate HCl Extended-Release Capsules CD included 188 pediatric patients 6 to 15 years old with ADHD exposed to Methylphenidate HCl Extended-Release Capsules CD. Patients received Methylphenidate HCl Extended-Release Capsules CD 20 mg, 40 mg, and/or 60 mg per day. The 188 patients were evaluated in the following studies: Study 1, a 3-week placebo-controlled clinical study consisting of a total of 314 pediatric patients (ages 6 to 15 years; Methylphenidate HCl Extended-Release Capsules CD n=155); Study 2, a placebo-controlled, crossover clinical study consisting of 25 pediatric patients (ages 7 to 12 years); and Study 3, an uncontrolled clinical study consisting of 8 pediatric patients (ages 6 to 10 years). Adverse Reactions Leading to Discontinuation of Treatment In the 3-week placebo-controlled, parallel-group trial, two Methylphenidate HCl Extended-Release Capsules CD-treated patients (1%) and no placebo-treated patients discontinued due to an adverse reaction (rash and pruritus; and headache, abdominal pain, and dizziness, respectively). Most Common Adverse Reactions The most common adverse reactions that occurred in 5% or more of patients treated with Methylphenidate HCl Extended-Release Capsules CD in a pool of Studies 1, 2 and 3 (ages 6 to 15 years) where the incidence in patients treated with Methylphenidate HCl Extended-Release Capsules CD was at least twice the incidence in placebo-treated patients were anorexia and insomnia. Adverse reactions that occurred in ≥5% of patients treated with Methylphenidate HCl Extended-Release Capsules CD and greater than placebo in pooled Studies, 1, 2, and 3 are presented in Table 2: Table 2: Adverse Reactions (≥5% and Greater than Placebo) in Pediatric Patients Ages 6 to 15 Years Receiving Methylphenidate HCl Extended-Release Capsules CD in Pooled Three to Four Week Trials Body System Preferred Term Methylphenidate HCl Extended-Release Capsules CD (n=188) % Placebo (n=190) % General Headache 12 8 Abdominal Pain (stomachache) 7 4 Digestive System Anorexia 9 2 Nervous System Insomnia 5 2 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Methylphenidate HCl Extended-Release Capsules CD and other methylphenid …

7 DRUG INTERACTIONS Table 3 describes clinically significant drug interactions with Methylphenidate HCl Extended-Release Capsules CD. Table 3: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of Methylphenidate HCl Extended-Release Capsules CD with MAOIs or within 14 days after discontinuing an MAOI is contraindicated. Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including Methylphenidate HCl Extended-Release Capsules CD, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) Methylphenidate HCl Extended-Release Capsules CD may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] . Halogenated Anesthetics Prevention or Management Avoid use of Methylphenidate HCl Extended-Release Capsules CD in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of halogenated anesthetics and Methylphenidate HCl Extended-Release Capsules CD may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms. Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant Methylphenidate HCl Extended-Release Capsules CD when there is a change in the Methylphenidate HCl Extended-Release Capsules CD or risperidone dosage. Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7 ) See Full Prescribing Information, for additional clinically significant drug interactions. ( 7 )

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylphenidate HCl Extended-Release Capsules CD, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the fetus associated with the use of central nervous system (CNS) stimulants 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 53 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 background risk of major birth defects and miscarriage in those with ADHD 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 HCl Extended-Release Capsules CD, 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. 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 (15 times 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 adults 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 adults on a mg/m 2 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 (~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 infant and no effects on milk production. Long-term neurodevelopmental effects on inf …

12.1 Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

11 DESCRIPTION Methylphenidate HCl Extended-Release Capsules CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl Extended-Release Capsules CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d , l (racemic)- threo -methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless, 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. Methylphenidate HCl Extended-Release Capsules CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents: 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide 20 mg capsules: FD&C Blue No. 2 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide 40 mg capsules: FDA/E172 Yellow Iron Oxide 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide formula

10 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. Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of a methylphenidate product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI). Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of Methylphenidate HCl Extended-Release Capsules CD should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. If an overdose of Methylphenidate HCl Extended-Release Capsules CD occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Methylphenidate HCl Extended-Release Capsules CD (methylphenidate HCl, USP) extended-release capsules are available in six strengths (see Table 4): Table 4: Strengths, Identifying Characteristics, and Packaging Configurations of Methylphenidate HCl Extended-Release Capsules CD Strength Capsule Color (cap/body) Imprinting on Capsule Cap Imprinting on Capsule Body Capsules per Bottle NDC Number 10 mg green/white “LANNETT 4579” in white letters “10 mg” in black letters 100 NDC 0527-4579-37 20 mg blue/white “LANNETT 4580” in white letters “20 mg” in black letters 100 NDC 0527-4580-37 30 mg reddish-brown/white “LANNETT 4581” in white letters “30 mg” in black letters 100 NDC 0527-4581-37 40 mg yellow ivory/white “LANNETT 4582” in black letters “40 mg” in black letters 100 NDC 0527-4582-37 50 mg purple/white “LANNETT 4583” in white letters “50 mg” in black letters 100 NDC 0527-4583-37 60 mg white/white capsules “LANNETT 4584” in black letters “60 mg” in black letters 100 NDC 0527-4584-37 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].