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Methylphenidate Hydrochloride 5 mg/5mL Solution, 500 mL — NDC 27808-058-01 (Billing 27808-0058-01)

by Cranbury Pharmaceuticals, LLC · 500 mL in 1 BOTTLE, PLASTIC

This is a package of 500 mL of Methylphenidate Hydrochloride 5 mg/5mL Solution from Cranbury Pharmaceuticals, LLC, marketed since Mar 2015 and currently FDA-listed; retail pharmacies pay about $0.0782 per mL (NADAC). It is this product's only package size.

NDC 27808-0058-01
🏷️ FDA NDC (as labeled) 27808-058-01 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) 27808-058-01
Product NDC 27808-058
11-digit billing NDC 27808005801
NCPDP billing unit ML — per mL (volume)
RxCUI 1091133, 1091341
UNII 4B3SC438HI
UPC 0327808059017
Application # ANDA091601
SPL Set ID e817377f-bc72-415a-acd2-7136746b2479
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 2015-03-04
Route ORAL
Dosage form SOLUTION
Substance METHYLPHENIDATE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 61400020102020
GPI class Methylphenidate HCl
GCN Seq No 054679
GCN 22685
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 5 MG/5 ML SOLN
FDB brand name Methylphenidate Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 054679
  • GCN: 22685
  • GPI-14 (Medi-Span): 61400020102020
  • HICL (First Databank): 001682
  • AHFS class code: 28:20.32.00
  • RxCUI (RxNorm): 1091133
Why two NDCs? The FDA registers this code as 27808-058-01 — 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 → 27808-0058-01. 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 5 MG/5 ML SOLN Ingredient Methylphenidate Hcl
📗 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 mLPer package
Retail pharmacies payNADAC · weekly $0.078 $39.10 / 500 ml
Medicaid paysCMS SDUD · 12 mo $0.1211 $60.55 / 500 ml
Medicare drug plans payPart D · Q2 2026 $0.1476 $73.80 / 500 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.171 $0.075
▼ Down 49% over the last 24 months.
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
27808-0058-01 You're viewing this Main listing 500 mL in 1 BOTTLE, PLASTIC 2015-03-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methylphenidate Hydrochloride 5 mg/5mLthis 27808-0058-01 Cranbury 500 ml $0.078 AA Availability likely —
Methylphenidate Hydrochloride 5 mg/5mL 70752-0131-14 QUAGEN 500 ml $0.078 AA Availability likely —
Methylphenidate Hydrochloride 5 mg/5mL 71930-0024-52 Eywa 500 ml $0.078 AA Availability likely —
Methylphenidate 5 mg/5mL 10702-0163-50 KVK-Tech, 500 ml $0.101 AA FDA listed +30%
Methylin 5 mg/5mL 59630-0750-50 SHIONOGI 500 ml $0.162 AA Availability likely +107%
Methylphenidate HCl 5 mg/5mL 39328-0054-50 Patrin 500 ml — AA FDA listed —
Methylphenidate Hydrochloride 5 mg/5mL 43386-0930-05 Lupin 500 ml — AA FDA listed —
Methylphenidate Hydrochloride 5 mg/5mL 43602-0177-05 Ascent 500 ml — AA FDA listed —
Methylphenidate Hydrochloride 5 mg/5mL 63629-1175-01 Bryant 500 ml — AA Discontinued —
Methylphenidate Hydrochloride 5 mg/5mL 67877-0602-91 Ascend 500 ml — AA FDA listed —
Methylphenidate Hydrochloride 5 mg/5mL 72162-1992-05 Bryant 500 ml — AA FDA listed —
Methylphenidate Hydrochloride 5 mg/5mL 72162-2040-05 Bryant 500 ml — AA 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
Mar 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerCranbury Pharmaceuticals, LLC
Application holderTRIS PHARMA INC
FDA applicationANDA091601 (ANDA)
Labeler code27808
First marketedMar 2015
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio44 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride oral solution 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, 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 oral solution, 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 oral solution 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 oral solution 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 oral solution, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing methylphenidate hydrochloride oral solution, 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.

🎯 Indications and Usage 72 words ▾

1 INDICATIONS AND USAGE Methylphenidate hydrochloride oral solution is indicated for the treatment of: • Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older • Narcolepsy Methylphenidate hydrochloride oral solution is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Pediatric patients 6 years and older: Starting dose is 5 mg twice daily (before breakfast and lunch); increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is not recommended. ( 2.2 ) 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. Maximum recommended daily dosage is 60 mg. ( 2 )

2.1Pretreatment Screening Prior to treating patients with methylphenidate hydrochloride oral solution, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions ( 5.10 )] .

2.2General Dosing Information Pediatric Patients 6 years of Age and Older The recommended starting dosage is 5 mg orally twice daily before breakfast and lunch (preferably 30 to 45 minutes before meals). Increase the dosage gradually, in increments of 5 mg to 10 mg weekly. Daily dosage above 60 mg is not recommended.

Adults Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. The maximum recommended daily dose is 60 mg. The average dosage is 20 to 30 mg daily.

For adult patients who are unable to sleep if medication is taken late in the day, administer the last dose before 6 p.m.

2.3Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue methylphenidate hydrochloride oral solution. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue methylphenidate hydrochloride oral solution.

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS Methylphenidate hydrochloride oral solution is a colorless, grape flavored liquid available in a 500 mL bottle in the following strengths: 5 mg per 5 mL 10 mg per 5 mL Oral solution: 5 mg per 5 mL and 10 mg per 5 mL. ( 3 )

⛔ Contraindications 115 words ▾

4 CONTRAINDICATIONS Methylphenidate hydrochloride oral solution is contraindicated in patients: with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6 )] . receiving 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 )] .

Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 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 oral solution, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride oral solution. ( 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 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 (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-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 oral solution 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 oral solution, 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 )

5.1Abuse, Misuse, and Addiction Methylphenidate hydrochloride oral solution has a high potential for abuse and misuse. The use of methylphenidate hydrochloride exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate hydrochloride oral solution can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence ( 9.2 )] .

Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride, 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 oral solution, 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 oral solution in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride oral solution to anyone else. Throughout methylphenidate hydrochloride treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid methylphenidate hydrochloride use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrythmia, coronary artery disease, or other serious cardiac disease.

5.3Increased Blood Pressur… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions 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 )] Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ), 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 following adverse reactions associated with the use of methylphenidate containing products were identified in clinical studies, postmarketing reports, or literature.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and infestations: nasopharyngitis Blood and the lymphatic system disorders: leukopenia, thrombocytopenia, anemia, pancytopenia Immune system disorders: hypersensitivity reactions, including angioedema and anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas 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, affect lability, mania, disorientation, libido changes Nervous system disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebral arteritis and/or occlusion, serotonin syndrome in combination with serotonergic drugs, migraine, motor and verbal tics Eye disorders: blurred vision, difficulties in visual accommodation, diplopia, mydriasis, increased intraocular pressure Cardiac disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris, sudden cardiac death, myocardial infarction, bradycardia, extrasystole Respiratory, thoracic and mediastinal disorders: cough, pharyngolaryngeal pain, dyspnea Gastrointestinal disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhea General disorders: fatigue, hyperpyrexia 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 angioneurotic edema, erythema, fixed drug eruption Musculoskeletal and connective tissue disorders: arthralgia, muscle cramps, rhabdomyolysis, myalgia, muscle twitching Renal and urinary disorders: hematuria Reproductive system and breast disorders: gynecomastia Urogenital disorders: priapism Vascular disorders: peripheral coldness, Raynaud’s phenomenon Investigations: weight loss Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain.

( 6 ) To report SUSPECTED ADVERSE REACTIONS contact Cranbury Pharmaceuticals, LLC at (732) 940 0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.1 )

7.1Clinically Important Drug Interactions with Methylphenidate Hydrochloride Oral Solution Table 1 presents clinically important drug interactions with methylphenidate hydrochloride oral solution. Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Oral Solution Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride oral solution, 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 oral solution with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical Impact: Methylphenidate hydrochloride oral solution may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] . Intervention: Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.

Halogenated Anesthetics Clinical Impact: Concomitant use of halogenated anesthetics and methylphenidate hydrochloride oral solution may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention: Avoid use of methylphenidate hydrochloride oral solution in patients being treated with anesthetics on the day of surgery. Risperidone Clinical Impact: Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS).

Intervention: Monitor for signs of EPS.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride oral solution, 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 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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults.

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 7 times the MRHD given to adults (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 oral solution, 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 65 times the MRHD of 60 mg/day given to adults on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the MRHD given to adults 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 (12 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 (4 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 (7 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 adults on a mg/m 2 basis).

8.2Lactation 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 infants from stimula… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride oral solution, 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 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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults.

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 7 times the MRHD given to adults (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 oral solution, 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 65 times the MRHD of 60 mg/day given to adults on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the MRHD given to adults 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 (12 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 (4 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 (7 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 adults on a mg/m 2 basis).

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride oral solution for the treatment of ADHD have been established in pediatric patients six years of age and older. The safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. The long-term efficacy of methylphenidate in pediatric patients has not been established.

Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions ( 5.6 )] . Juvenile Animal Toxicity Data In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10).

When these animals were tested as adults (postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2 basis). The no effect level for juvenile neurobehavioral development in rats (5 mg/kg/day) is less than the MRHD given to children on a mg/m 2 basis.

The clinical significance of the long-term behavioral effects observed in rats is unknown.

🧓 Geriatric Use 15 words ▾

8.5Geriatric Use Methylphenidate hydrochloride oral solution has not been studied in the geriatric population.

🆘 Overdosage 109 words ▾

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.

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 ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics 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 blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Cardiac Electrophysiology A formal QT study has not been conducted in subjects taking methylphenidate hydrochloride oral solution. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride oral solution, on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of 40 mg dexmethylphenidate hydrochloride extended-release capsule in 75 healthy volunteers. Electrocardiograms were collected up to 12 hours postdose.

Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship.

12.3Pharmacokinetics Absorption Following a single dose administration of 20 mg methylphenidate hydrochloride oral solution and 20 mg tablet of methylphenidate hydrochloride in healthy volunteers under fasted conditions, time to peak plasma concentration (T max ) of methylphenidate was at 1 to 2 hours after dosing, and: The mean peak plasma concentration (C max ) of methylphenidate was 9.1 ng/mL and 9.8 ng/mL, respectively. The mean area under concentration curve (AUC) of methylphenidate was 46.7 hour*ng/mL and 50.0 hour*ng/mL, respectively.

Effect of Food Ingestion of a high-fat meal with methylphenidate hydrochloride oral solution increased methylphenidate mean C max and AUC by about 13% and 25%, respectively. Time to C max (T max ) was delayed by approximately 1 hour. Distribution Plasma protein binding is 10% to 33%.

The volume of distribution was 2.65 ±

1.11L/kg for d-methylphenidate and 1.80 ±

0.91L/kg for l-methylphenidate. Elimination The mean terminal half-life (t 1/2 ) of methylphenidate was 2.7 hours following administration of 20 mg methylphenidate hydrochloride oral solution. The systemic clearance is 0.40 ±

0.12L/h/kg for d-methylphenidate and 0.73 ±

0.28L/h/kg for l-methylphenidate. Metabolism Methylphenidate is metabolized primarily by deesterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine.

The main urinary metabolite was ritalinic acid, accounting for approximately 80% of the dose. Specific Populations Male and Female Patients, Racial Groups, and Age The effect of gender, race, and age on the pharmacokinetics of methylphenidate after methylphenidate hydrochloride oral solution administration have not been studied. Patients with Renal Impairment Methylphenidate hydrochloride oral solution has not been studied in patients with renal impairment.

Since renal clearance is not an important route of methylphenidate clearance, renal impairment is expected to have little effect on the pharmacokinetics of methylphenidate hydrochloride oral solution. Patients with Hepatic Impairment Methylphenidate hydrochloride oral solution has not been studied in patients with hepatic impairment. Since methylphenidate is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body, hepatic impairment is expected to have minimal e… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 23 words ▾

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

📦 How Supplied / Storage and Handling 80 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Methylphenidate hydrochloride oral solution 5 mg per 5 mL is a colorless, grape flavored liquid. It is supplied in bottles of 500 mL, NDC 27808-058-01. Methylphenidate hydrochloride oral solution 10 mg per 5 mL is a colorless grape flavored liquid.

It is supplied in bottles of 500 mL, NDC 27808-059-01. Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container with child-resistant closure.

📋 Description 133 words ▾

11 DESCRIPTION Methylphenidate hydrochloride oral solution is a CNS stimulant available as 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, Methylphenidate hydrochloride is ( d,l racemic) 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. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP.

In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: artificial grape flavor, glycerin, hydrochloric acid, polyethylene glycol 1450, and purified water. methylphenidatestructure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION 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 oral solution, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 ), Overdosage ( 10 )] . Advise patients to store methylphenidate hydrochloride oral solution in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride oral solution 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 oral solution 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 and Precautions ( 5.2 )] . Increased Blood Pressure and Heart Rate Instruct patients that methylphenidate hydrochloride oral solution can elevate blood pressure and heart rate [see Warnings and Precautions ( 5.3 )] .

Psychiatric Adverse Reactions Advise patients that methylphenidate hydrochloride oral solution, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions ( 5.4 )] . Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions ( 5.5 )] .

Circulation Problems in Fingers and Toes (Peripheral Vasculopathy, Including Raynaud’s Phenomenon) Instruct patients 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 oral solution.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions ( 5.6 )] . Long-Term Suppression of Growth in Pediatric Patients Advise patients that methylphenidate hydrochloride oral solution may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions ( 5.7 )] . Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with methylphenidate hydrochloride oral solution [see Warnings and Precautions ( 5.9 )] .

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 oral solution. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions ( 5.10 )] . Pregnancy Exposure Registry Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride oral solution during pregnancy [see Use in Specific Populations ( 8.1 )] .

Manufactured by: Tris Pharma Inc. Monmouth Junction, NJ 08852 For: Cranbury Pharmaceuticals, LLC Monmouth Junction, NJ 08852 LB8477 Rev. 05 01/2025

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Methylphenidate Hydrochloride Oral Solution CII (METH il FEN i date) 5 mg/5 mL and 10 mg/5 mL Rx only What is the most important information I should know about Methylphenidate Hydrochloride Oral Solution? Methylphenidate Hydrochloride Oral Solution may cause serious side effects, including: Abuse , misuse, and addiction. Methylphenidate Hydrochloride Oral Solution has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of Methylphenidate Hydrochloride Oral Solution, 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 Oral Solution 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 Oral Solution and will monitor you or your child during treatment.

Methylphenidate Hydrochloride Oral Solution may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Methylphenidate Hydrochloride Oral Solution to anyone else. See “What is Methylphenidate Hydrochloride Oral Solution?” for more information.

Keep Methylphenidate Hydrochloride Oral Solution in a safe place and properly dispose of any unused medicine. See “How should I store Methylphenidate Hydrochloride Oral Solution?” 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.

Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Methylphenidate Hydrochloride Oral Solution.

Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Methylphenidate Hydrochloride Oral Solution. Increased blood pressure and heart rate.

Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Oral Solution. Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) 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 during treatment with Methylphenidate Hydrochloride Oral Solution, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What is Methylphenidate Hydrochloride Oral Solution? Methylphenidate Hydrochloride Oral Solution is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.

Methylphenidate Hydrochloride Oral Solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. It is not known if Methylphenidate Hydrochloride Oral Solution is safe and effective for use in children under 6 years of age. Methylphenidate Hydrochloride Oral Solution is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.

Keep Methylphenidate Hydrochloride Ora… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption Following a single dose administration of 20 mg methylphenidate hydrochloride oral solution and 20 mg tablet of methylphenidate hydrochloride in healthy volunteers under fasted conditions, time to peak plasma concentration (T max ) of methylphenidate was at 1 to 2 hours after dosing, and: The mean peak plasma concentration (C max ) of methylphenidate was 9.1 ng/mL and 9.8 ng/mL, respectively. The mean area under concentration curve (AUC) of methylphenidate was 46.7 hour*ng/mL and 50.0 hour*ng/mL, respectively.

Effect of Food Ingestion of a high-fat meal with methylphenidate hydrochloride oral solution increased methylphenidate mean C max and AUC by about 13% and 25%, respectively. Time to C max (T max ) was delayed by approximately 1 hour. Distribution Plasma protein binding is 10% to 33%.

The volume of distribution was 2.65 ±

1.11L/kg for d-methylphenidate and 1.80 ±

0.91L/kg for l-methylphenidate. Elimination The mean terminal half-life (t 1/2 ) of methylphenidate was 2.7 hours following administration of 20 mg methylphenidate hydrochloride oral solution. The systemic clearance is 0.40 ±

0.12L/h/kg for d-methylphenidate and 0.73 ±

0.28L/h/kg for l-methylphenidate. Metabolism Methylphenidate is metabolized primarily by deesterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine.

The main urinary metabolite was ritalinic acid, accounting for approximately 80% of the dose. Specific Populations Male and Female Patients, Racial Groups, and Age The effect of gender, race, and age on the pharmacokinetics of methylphenidate after methylphenidate hydrochloride oral solution administration have not been studied. Patients with Renal Impairment Methylphenidate hydrochloride oral solution has not been studied in patients with renal impairment.

Since renal clearance is not an important route of methylphenidate clearance, renal impairment is expected to have little effect on the pharmacokinetics of methylphenidate hydrochloride oral solution. Patients with Hepatic Impairment Methylphenidate hydrochloride oral solution has not been studied in patients with hepatic impairment. Since methylphenidate is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body, hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate hydrochloride oral solution.

🧬 Pharmacodynamics 180 words ▾

12.2Pharmacodynamics 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 blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Cardiac Electrophysiology A formal QT study has not been conducted in subjects taking methylphenidate hydrochloride oral solution. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride oral solution, on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of 40 mg dexmethylphenidate hydrochloride extended-release capsule in 75 healthy volunteers. Electrocardiograms were collected up to 12 hours postdose.

Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship.

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a Schedule II controlled substance.

9.2Abuse Methylphenidate hydrochloride oral solution 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 ( 5.1 )]. Methylphenidate hydrochloride oral solution 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 healthcare 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 oral solution, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection.

9.3Dependence Physical Dependence Methylphenidate hydrochloride oral solution 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 include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance Methylphenidate hydrochloride oral solution 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).

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 5 times the maximum recommended human dose (MRHD) of 60 mg/kg given to adults on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type.

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 7 times the MRHD (adults) on a mg/m 2 basis.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes.

Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available.

Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 13 times the maximum recommended human dose of 60 mg/day given to adults on a mg/m 2 basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 5 times the maximum recommended human dose (MRHD) of 60 mg/kg given to adults on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type.

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 7 times the MRHD (adults) on a mg/m 2 basis.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes.

Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available.

Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 13 times the maximum recommended human dose of 60 mg/day given to adults on a mg/m 2 basis.

📄 Recent Major Changes 29 words ▾

Boxed Warning 10/2023 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 10/2023 Warnings and Precautions ( 5.1 , 5.2 , 5.8 , 5.9 , 5.10 ) 10/2023

📄 Package Label / Principal Display Panel 52 words ▾

NDC 27808-058-01 Methylphenidate Hydrochloride Oral Solution CII 5 mg per 5 mL PHARMACIST: Dispense the Medication Guide to each patient. Rx only 500 mL 5mg/5mL label

NDC 27808-059-01 Methylphenidate Hydrochloride Oral Solution CII 10 mg per 5 mL PHARMACIST: Dispense the Medication Guide to each patient. Rx only 500 mL 10mg/5mL label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
36K
Units reimbursed last 4 qtrs
10.2M
Gross reimbursed last 4 qtrs
$1.24M
Avg / prescription
$34.41
Avg / unit
$0.1211
Latest quarter Q1 2026
8.5KRx
Medicaid pays / mL
$0.1211
gross reimbursed
vs
NADAC / mL
$0.0782
acquisition cost
=
Spread
+$0.0429
+55% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 14,936 Rx Managed care · 21,099 Rx
State Medicaid map
Alaska: no data reported AK Maine: 129,412 units · 9,277 per 100k residents ME Washington: 235,760 units · 3,018 per 100k residents WA Idaho: 95,630 units · 4,869 per 100k residents ID Montana: 23,045 units · 2,036 per 100k residents MT North Dakota: 11,070 units · 1,414 per 100k residents ND Minnesota: 213,045 units · 3,714 per 100k residents MN Wisconsin: 284,942 units · 4,821 per 100k residents WI Michigan: 251,179 units · 2,503 per 100k residents MI New York: 806,401 units · 4,120 per 100k residents NY Vermont: 139,343 units · 21,537 per 100k residents VT New Hampshire: 44,110 units · 3,146 per 100k residents NH Oregon: 125,938 units · 2,975 per 100k residents OR Nevada: 28,697 units · 898 per 100k residents NV Wyoming: 6,081 units · 1,041 per 100k residents WY South Dakota: 8,376 units · 911 per 100k residents SD Iowa: 132,025 units · 4,117 per 100k residents IA Illinois: 124,396 units · 991 per 100k residents IL Indiana: 320,492 units · 4,671 per 100k residents IN Ohio: 532,707 units · 4,520 per 100k residents OH Pennsylvania: 494,247 units · 3,813 per 100k residents PA New Jersey: 205,020 units · 2,207 per 100k residents NJ Massachusetts: 134,540 units · 1,922 per 100k residents MA California: 330,554 units · 848 per 100k residents CA Utah: 37,703 units · 1,103 per 100k residents UT Colorado: 124,385 units · 2,116 per 100k residents CO Nebraska: 119,073 units · 6,020 per 100k residents NE Missouri: 389,884 units · 6,293 per 100k residents MO Kentucky: 247,084 units · 5,459 per 100k residents KY West Virginia: 283,272 units · 16,004 per 100k residents WV Virginia: 246,513 units · 2,828 per 100k residents VA Maryland: 188,433 units · 3,049 per 100k residents MD Connecticut: 55,345 units · 1,530 per 100k residents CT Rhode Island: 30,643 units · 2,798 per 100k residents RI Arizona: 22,253 units · 299 per 100k residents AZ New Mexico: 46,089 units · 2,180 per 100k residents NM Kansas: 76,604 units · 2,606 per 100k residents KS Arkansas: no data reported AR Tennessee: 417,425 units · 5,858 per 100k residents TN North Carolina: 636,717 units · 5,876 per 100k residents NC South Carolina: 293,041 units · 5,454 per 100k residents SC Delaware: 107,334 units · 10,411 per 100k residents DE Oklahoma: 224,780 units · 5,546 per 100k residents OK Louisiana: 219,965 units · 4,809 per 100k residents LA Mississippi: 112,413 units · 3,824 per 100k residents MS Alabama: 347,199 units · 6,797 per 100k residents AL Georgia: 565,738 units · 5,130 per 100k residents GA D.C.: 2,178 units · 321 per 100k residents DC Hawaii: no data reported HI Texas: 203,810 units · 668 per 100k residents TX Florida: 560,415 units · 2,479 per 100k residents FL
Units reimbursed · per 100k residents
29921,537
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 21,537 /100k
2 West Virginia 16,004 /100k
3 Delaware 10,411 /100k
4 Maine 9,277 /100k
5 Alabama 6,797 /100k
6 Missouri 6,293 /100k
7 Nebraska 6,020 /100k
8 North Carolina 5,876 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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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.