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Methylphenidate Hydrochloride 2.5 mg Tablet, Chewable, 100-count — NDC 43386-0570-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Methylphenidate Hydrochloride 2.5 mg Tablet, Chewable, 100-count — NDC 43386-570-01 (Billing 43386-0570-01)

by Lupin Pharmaceuticals,Inc. · 100 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 100 tablets of Methylphenidate Hydrochloride 2.5 mg Tablet, Chewable from Lupin Pharmaceuticals,Inc., marketed since Apr 2015 and currently FDA-listed; retail pharmacies pay about $2.03 per tablet (NADAC). It is this product's only package size.

NDC 43386-0570-01
🏷️ FDA NDC (as labeled) 43386-570-01 billing pads the product segment with a zero
Rx only Generic On market CII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 7, 2022 — Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind. (RISING PHARMACEUTICALS) · FDA recall D-0573-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43386-570-01
Product NDC 43386-570
11-digit billing NDC 43386057001
NCPDP billing unit EA — each (per item)
RxCUI 1091152, 1091322, 1091389
UNII 4B3SC438HI
Application # ANDA204115
SPL Set ID 5bfe50ed-171f-4c40-bc0b-20c68e8e2025
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-04-06
Route ORAL
Dosage form TABLET, CHEWABLE
Substance METHYLPHENIDATE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 61400020100510
GPI class Methylphenidate HCl
GCN Seq No 054676
GCN 22682
HICL code 001682
Ingredient (HICL) Methylphenidate Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2V
Therapeutic class — specific (HIC3) Tx For Attention Deficit-Hyperact(Adhd)/Narcolepsy
AHFS code 28:20.32.00
AHFS class Respiratory And Cns Stimulants
FDB label name METHYLPHENIDATE 2.5 MG CHEW TB
FDB brand name Methylphenidate Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 054676
  • GCN: 22682
  • GPI-14 (Medi-Span): 61400020100510
  • HICL (First Databank): 001682
  • AHFS class code: 28:20.32.00
  • RxCUI (RxNorm): 1091152
Why two NDCs? The FDA registers this code as 43386-570-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0570-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant
Drug family (ATC) Centrally acting sympathomimetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METHYLPHENIDATE 2.5 MG CHEW TB Ingredient Methylphenidate Hcl
📖 What it is MedlinePlus · NLM

Methylphenidate is used to control symptoms of attention deficit hyperactivity disorder (ADHD; condition that makes it hard to pay attention, control your behavior, and remain still or quiet) and to treat narcolepsy (condition that causes people to be very sleepy during the day and to fall asleep suddenly). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It mainly treats ADHD, and some products are also used for narcolepsy. The exact approval depends on the product and the age group. Your prescriber chooses the right one for you.
  • It depends on your product. Many extended-release forms are taken once daily in the morning, while Jornay PM is taken in the evening. Swallow extended-release tablets whole, and fo...
  • The most common ones are decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety and dizziness. Children and teens may get upper stomach pain. Call your doctor i...
  • Call for chest pain, fainting, a racing heartbeat, hallucinations, seizures, painful erections that won’t go away, or color changes in your fingers or toes. Also call if you notice...
📖 Read our full Methylphenidate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.026 $202.64 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.47 $147.21 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
May 2021 $2.026 $2.026
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43386-0570-01 You're viewing this Main listing 100 TABLET, CHEWABLE in 1 BOTTLE 2015-04-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methylphenidate Hydrochloride 2.5 mg 31722-0926-01 Camber 100 tablets $1.299 AB Availability likely save 36%
Methylphenidate Hydrochloride 2.5 mg 64980-0221-01 Rising 100 tablets $1.299 AB Availability likely save 36%
Methylphenidate Hydrochloride 2.5 mgthis 43386-0570-01 Lupin 100 tablets $2.026 — FDA listed —
Methylphenidate Hydrochloride 2.5 mg 63629-1921-01 Bryant 100 tablets — AB Discontinued —
Methylphenidate Hydrochloride 2.5 mg 72865-0125-01 XLCare 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRound
ImprintNL;572
Size13 mm
ScoringNot scored
FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII XJ6S9RV06F
    Maltose is a simple sugar made from grain starches. It works as a sweetener and filler in medicines to improve taste and add bulk to tablets and powders.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLupin Pharmaceuticals,Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA204115 (ANDA)
Labeler code43386
First marketedApr 2015
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio89 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~3 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride chewable tablets 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 hydrochloride chewable tablets, can result in overdose and death ( see Overdosage ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride chewable 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 chewable 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 and Drug Abuse and Dependence).

USE IN CHILDREN LESS THAN SIX YEARS OF AGE Methylphenidate hydrochloride chewable tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. DRUG ABUSE AND DEPENDENCE Controlled Substance Methylphenidate hydrochloride chewable tablets contains methylphenidate a Schedule II controlled substance. Abuse Methylphenidate hydrochloride chewable tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see Warnings and Precautions).Methylphenidate hydrochloride chewable tablets can be diverted for non-medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations),and possible tolerance or physical dependence.

Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including Methylphenidate hydrochloride chewable tablets, can result in overdose and death (see Overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Dependence Physical Dependence Methylphenidate hydrochloride chewable tablets may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including methylphenidate hydrochloride chewable tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance Methylphenidate hydrochloride chewable tablets may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose)…

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Attention Deficit Disorders , Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test.

Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired.

The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis.

Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Prior to treating patients with methylphenidate hydrochloride chewable tablet 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). • the family history and clinically evaluate patients for motor or verbal tics or Tourette's syndrome (see WARNINGS). Dosage should be individualized according to the needs and responses of the patient. Directions – Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid.

Taking this product without enough liquid may cause choking. See choking warning. Adults Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals.

Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate.

Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m. Children (6 years and over) Methylphenidate hydrochloride chewable tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue methylphenidate hydrochloride chewable tablet. Methylphenidate hydrochloride chewable tablet should be periodically discontinued to assess the patient's condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Chewable Tablets : Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

⛔ Contraindications 52 words ▾

CONTRAINDICATIONS Methylphenidate hydrochloride chewable tablet is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug. Methylphenidate hydrochloride chewable tablets are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

⚠️ Warnings ~3 min read ▾

WARNINGS Abuse, Misuse, and Addiction Methylphenidate hydrochloride chewable tablets has a high potential for abuse and misuse. The use of methylphenidate hydrochloride chewable 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 chewable tablets can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE and DEPENDENCE).

Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride chewable tablets can result in overdose and death (see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride chewable 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 in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride chewable tablets to anyone else. Throughout methylphenidate hydrochloride chewable tablets treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 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 dosages.

Avoid methylphenidate hydrochloride chewable tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric Adverse Reactions Exacerbations of Pre-Existing Psychosis – CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease – CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression) New Psychotic or Manic Symptoms – CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania.

In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consideration discontinuing methylphenidate hydrochloride chewable tablets. Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures.

In the presence of seizures, the drug should be discontinued. Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose.

Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation): Patients who develop abnormally sustained or frequent and painful erections should seek immediate…

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolysis increased intraocular pressure and glaucoma, motor and verbal tics.

There have been rare reports of Tourette's syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abdominal liver function, ranging from transaminase elevation to severe hepatic injury; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss, serotonin syndrome in combination with serotonergic drugs.

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

🔄 Drug Interactions 187 words ▾

Drug Interactions Monoamine Oxidase Inhibitors (MAOI) Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride chewable tablet can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure (see CONTRAINDICATIONS). Concomitant use of methylphenidate hydrochloride chewable tablet with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.

Antihypertensive Drugs Methylphenidate hydrochloride chewable tablet may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Risperidone 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).

Monitor for signs of EPS. Methylphenidate hydrochloride chewable tablets may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.

Human pharmacologic studies have shown that methylphenidate hydrochloride chewable tablet may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with methylphenidate hydrochloride chewable tablet.

🆘 Overdosage 111 words ▾

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.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Methylphenidate is a racemic mixture comprised of the d - and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate HCl is a central nervous system (CNS) stimulant.

The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. There is neither specific evidence which clearly establishes the mechanism whereby methylphenidate hydrochloride chewable tablets produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Pharmacokinetics Absorption Methylphenidate hydrochloride chewable tablets are readily absorbed. Following oral administration of methylphenidate hydrochloride chewable tablets, peak plasma methylphenidate concentrations are achieved at about 1 to 2 hours. Methylphenidate hydrochloride chewable tablets have been shown to be bioequivalent to Ritalin ® tablet.

The mean C max following a 20 mg dose is approximately 10 ng/mL. Food Effect In a study in adult volunteers investigating the effects of a high-fat meal on the bioavailability of methylphenidate hydrochloride chewable tablets at a dose of 20 mg, the presence of food delayed the peak concentrations by approximately 1 hour (1.5 hours, fasted and 2.4 hours, fed). Overall, a high-fat meal increased the AUC of methylphenidate hydrochloride chewable tablets by about 20%, on average.

Through a cross-study comparison, the magnitude of food effect is found to be comparable between the methylphenidate hydrochloride chewable tablets and Ritalin, the immediate release tablet. Metabolism and Excretion In humans, methylphenidate is metabolized primarily via deesterification to alphaphenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.

After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose. The pharmacokinetics of the methylphenidate hydrochloride chewable tablets have been studied in healthy adult volunteers.

The mean terminal half-life (t ½ ) of methylphenidate following administration of 20 mg methylphenidate hydrochloride chewable tablets (t ½ = 3 hours) is comparable to the mean terminal t ½ following administration of Ritalin (methylphenidate hydrochloride immediate-release tablets) (t ½ = 2.8 hours) in healthy adult volunteers. Special Populations Gender – The effect of gender on the pharmacokinetics of methylphenidate after methylphenidate hydrochloride chewable tablets administration has not been studied. Race – The influence of race on the pharmacokinetics of methylphenidate after methylphenidate hydrochloride chewable tablets administration has not been studied.

Age – The pharmacokinetics of methylphenidate after methylphenidate hydrochloride chewable tablets administration have not been studied in pediatrics. Renal Insufficiency There is no experience with the use of methylphenidate hydrochloride chewable tablets in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid.

Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of methylphenidate hydrochloride chewable tablets. Hepatic Insufficiency There is no experience with the use of methylphenidate hydrochloride chewable tablets in patients wit…

📦 How Supplied / Storage and Handling 191 words ▾

HOW SUPPLIED Each methylphenidate hydrochloride chewable tablet 2.5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "570" below on the one side and plain on the other side. Bottles of 100 .........NDC 43386-570-01 Each methylphenidate hydrochloride chewable tablet 5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "571" below on the one side and plain on the other side. Bottles of 100 .........NDC 43386-571-01 Each methylphenidate hydrochloride chewable tablet 10 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above the bisect and "572" below the bisect on one side and plain on the other side.

Bottles of 100 .........NDC 43386-572-01 Protect from moisture. Dispense in tight container with child-resistant closure. Storage Store at 20º to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Ritalin is a registered trademark of Novartis Corporation. Manufactured by: Novel Laboratories Inc. 400 Campus Drive Somerset, NJ 08873 USA Manufactured for: Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202 SAP Code: 274932 Rev. 11/2023

📦 Storage and Handling 47 words ▾

Storage Store at 20º to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin is a registered trademark of Novartis Corporation. Manufactured by: Novel Laboratories Inc. 400 Campus Drive Somerset, NJ 08873 USA Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 274932 Rev. 11/2023

📋 Description 106 words ▾

DESCRIPTION Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus.

It is soluble in water, alcohol, and chloroform. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid.

Chemical Structure

💬 Information for Patients ~3 min read ▾

Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride chewable tablet, which can lead to overdose and death, and proper disposal of any unused drug (see WARNINGS and PRECAUTIONS, DRUG ABUSE AND DEPENDENCE, OVERDOSAGE). Advise patients to store methylphenidate hydrochloride chewable tablet in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride chewable tablet to anyone else.

Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate hydrochloride chewable tablet use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease (see WARNINGS). Increased Blood Pressure and Heart Rate Advise patients that methylphenidate hydrochloride chewable tablet can elevate blood pressure and heart rate (see WARNINGS).

Psychiatric Adverse Reactions Advice patients that methylphenidate hydrochloride chewable tablet, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania (see WARNINGS). Priapism Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism.

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud's Phenomenon] Instruct patients beginning treatment with methylphenidate hydrochloride chewable tablets about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride chewable tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that methylphenidate hydrochloride chewable tablet can cause slowing of growth and weight loss (see Warnings).

Increased Intraocular Pressure and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with methylphenidate hydrochloride chewable tablet (see Warnings). Motor and Verbal Tics, and Worsening of Tourette's syndrome Advise patients that motor and verbal tics and worsening of Tourette's syndrome may occur during treatment with methylphenidate hydrochloride chewable tablet. Instruct the patients to notify their healthcare provider if emergence or worsening of tics or Tourette's syndrome occurs (see WARNINGS).

Choking – Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Directions – Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

Phenylketonurics – Phenylalanine is a component of aspartame. Each 2.5 mg methylphenidate hydrochloride chewable tablet contains 0.42 mg of phenylalanine; each 5.0 mg methylphenidate hydrochloride chewable tablet contains 0.84 mg of phenylalanine…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Methylphenidate Hydrochloride Chewable Tablets CII 2.5 mg, 5 mg, and 10 mg Read the Medication Guide that comes with methylphenidate hydrochloride chewable tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your or your child's treatment with methylphenidate hydrochloride chewable tablets.

What is the most important information I should know about methylphenidate hydrochloride chewable tablets? Methylphenidate hydrochloride chewable tablets may cause serious side effects, including: Abuse, misuse, and addiction . Methylphenidate hydrochloride chewable tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of methylphenidate hydrochloride chewable tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride chewable tablets or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride chewable tablets and will monitor you or your child during treatment.

Methylphenidate hydrochloride chewable tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give methylphenidate hydrochloride chewable tablets to anyone else. See " What Are methylphenidate hydrochloride chewable tablets ?" for more information.

Keep methylphenidate hydrochloride chewable tablets in a safe place and properly dispose of any unused medicine. See " How should I store methylphenidate hydrochloride chewable tablets ?" for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Heart-related problems : sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems Your healthcare provider should check you or your child carefully for heart problems before starting methylphenidate hydrochloride chewable tablets Your healthcare provider should check you or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride chewable tablets Call your healthcare provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride chewable tablets.

Mental (Psychiatric) problems: All Patient new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility Children and Teenagers new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking methylphenidate hydrochloride chewable tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Tell your healthcare provider if you have or your child has numbness, pain, skin color change, or sensitivity to temp…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.