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Dexmethylphenidate Hydrochloride Extended-Release 25 mg Capsule, Extended Release, 100-count — NDC 00527-8110-37 package photo

Dexmethylphenidate Hydrochloride Extended-Release 25 mg Capsule, Extended Release, 100-count

by Lannett Company, Inc. · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8110-37)
NDC 00527-8110-37
🏷️ FDA NDC (as labeled) 0527-8110-37 billing pads the labeler segment with a zero
Rx only Generic On market CII
🗂️ Data synced 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 Dexmethylphenidate 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 III · Jun 1, 2026 — Labeling: Incorrect or Missing Lot and/or Exp Date (Sandoz Inc) · FDA recall D-0608-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0527-8110-37
Product NDC 0527-8110
11-digit billing NDC 00527811037
NCPDP billing unit EA — each (per item)
RxCUI 899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932
UNII 1678OK0E08
UPC 0305278113378
Application # ANDA210279
SPL Set ID edad7c67-a872-41ad-a8bd-169278693cc2
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 2018-10-09
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance DEXMETHYLPHENIDATE HYDROCHLORIDE
GPI-14 61400016107045
GPI class Dexmethylphenidate HCl ER
GCN Seq No 067692
GCN 30305
HICL code 022987
Ingredient (HICL) Dexmethylphenidate 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 DEXMETHYLPHENIDATE ER 25 MG CP
FDB brand name Dexmethylphenidate Hcl Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0527-8110-37 — a 4-4-2 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 labeler segment → 00527-8110-37. 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.

🏭 Manufacturer & labeler

LabelerLannett Company, Inc.
Application holderADARE PHARMACEUTICALS INC
FDA applicationANDA210279 (ANDA)
Labeler code00527
First marketedOct 2018
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio171 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.

🩺 Clinical

Label name DEXMETHYLPHENIDATE ER 25 MG CP Ingredient Dexmethylphenidate Hcl
📖 What it is MedlinePlus · NLM

Dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Dexmethylphenidate is essentially the more active half of methylphenidate — think of it as a more refined version. Regular methylphenidate (like Ritalin) is a mix of two mirror-ima...
  • What exactly is dexmethylphenidate and how is it different from regular methylphenidate (Ritalin)?
  • Either way is fine — dexmethylphenidate can be taken with or without food. If you're taking the extended-release capsule and you can't swallow it whole, you can open it and sprinkl...
  • Should I take this with food or on an empty stomach?
📖 Read our full Dexmethylphenidate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color blue / white / green
ShapeCapsule
Imprint113
Size23 mm
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 161H3B14U2
    A synthetic plastic polymer used as an enteric coating on tablets and capsules. It dissolves in the intestines rather than the stomach, controlling where and when the medicine is released in the digestive tract.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

14 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.

💲 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 $1.746 $174.60 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $2.15 $215.08 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $2.58 $257.72 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $2.689 $1.717
▼ Down 1% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexmethylphenidate Hydrochloride 25 mg 00093-5045-01 Teva 100 capsules $1.746 AB Availability likely —
Dexmethylphenidate hydrochloride 25 mg 00115-1709-01 Amneal 100 capsules $1.746 AB Availability likely —
Dexmethylphenidate Hydrochloride Extended-Release 25 mgthis 00527-8110-37 Lannett 100 capsules $1.746 AB Availability likely —
Dexmethylphenidate Hydrochloride 25 mg 31722-0233-01 Camber 100 capsules $1.746 AB Availability likely —
Dexmethylphenidate Hydrochloride 25 mg 49884-0333-01 Par 100 capsules $1.746 AB Availability likely —
Dexmethylphenidate Hydrochloride 25 mg 70010-0008-01 Granules 100 capsules $1.746 AB Availability likely —
Focalin XR 25 mg 00078-0608-05 Novartis 100 capsules $5.129 AB Discontinued +194%
Focalin XR 25 mg 66758-0239-01 Sandoz 100 capsules $5.136 AB Availability likely +194%
Dexmethylphenidate Hydrochloride 25 mg 63629-2174-01 Bryant 100 capsules — AB FDA listed —
Dexmethylphenidate Hydrochloride 25 mg 72162-1493-01 Bryant 100 capsules — 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

🏛️
2018
On the market since
Oct 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ 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 00527-8110-37, 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 – Q4 2025 · 4 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
22.7K
Units reimbursed last 4 qtrs
690.6K
Gross reimbursed last 4 qtrs
$1.49M
Avg / prescription
$65.38
Avg / unit
$2.1508
Latest quarter Q4 2025
6KRx
Medicaid pays / ea
$2.1508
gross reimbursed
vs
NADAC / ea
$1.7460
acquisition cost
=
Spread
+$0.4048
+23% vs cost
What Medicaid paid per ea (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 ⓘ
45% FFS 55% MCO
Fee-for-service · 10,323 Rx Managed care · 12,397 Rx
State Medicaid map
Alaska: no data reported AK Maine: 7,554 units · 542 per 100k residents ME Washington: 5,584 units · 71.5 per 100k residents WA Idaho: 2,838 units · 145 per 100k residents ID Montana: 980 units · 86.6 per 100k residents MT North Dakota: 930 units · 119 per 100k residents ND Minnesota: 12,004 units · 209 per 100k residents MN Wisconsin: 42,817 units · 724 per 100k residents WI Michigan: 38,960 units · 388 per 100k residents MI New York: 21,363 units · 109 per 100k residents NY Vermont: 4,516 units · 698 per 100k residents VT New Hampshire: 2,536 units · 181 per 100k residents NH Oregon: 2,566 units · 60.6 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 3,533 units · 384 per 100k residents SD Iowa: 15,484 units · 483 per 100k residents IA Illinois: 4,654 units · 37.1 per 100k residents IL Indiana: 16,982 units · 247 per 100k residents IN Ohio: 35,622 units · 302 per 100k residents OH Pennsylvania: 19,624 units · 151 per 100k residents PA New Jersey: 6,076 units · 65.4 per 100k residents NJ Massachusetts: 18,614 units · 266 per 100k residents MA California: 15,832 units · 40.6 per 100k residents CA Utah: 2,340 units · 68.5 per 100k residents UT Colorado: 6,198 units · 105 per 100k residents CO Nebraska: 17,849 units · 902 per 100k residents NE Missouri: 24,952 units · 403 per 100k residents MO Kentucky: 19,021 units · 420 per 100k residents KY West Virginia: 25,417 units · 1,436 per 100k residents WV Virginia: 10,862 units · 125 per 100k residents VA Maryland: 8,652 units · 140 per 100k residents MD Connecticut: 6,361 units · 176 per 100k residents CT Rhode Island: 1,588 units · 145 per 100k residents RI Arizona: 6,077 units · 81.8 per 100k residents AZ New Mexico: 3,698 units · 175 per 100k residents NM Kansas: 7,623 units · 259 per 100k residents KS Arkansas: 18,471 units · 602 per 100k residents AR Tennessee: 41,987 units · 589 per 100k residents TN North Carolina: 68,200 units · 629 per 100k residents NC South Carolina: 20,955 units · 390 per 100k residents SC Delaware: 5,788 units · 561 per 100k residents DE Oklahoma: 330 units · 8.1 per 100k residents OK Louisiana: 21,714 units · 475 per 100k residents LA Mississippi: 13,362 units · 454 per 100k residents MS Alabama: 19,375 units · 379 per 100k residents AL Georgia: 8,310 units · 75.3 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 30,786 units · 101 per 100k residents TX Florida: 21,609 units · 95.6 per 100k residents FL
Units reimbursed · per 100k residents
8.11,436
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 West Virginia 1,436 /100k
2 Nebraska 902 /100k
3 Wisconsin 724 /100k
4 Vermont 698 /100k
5 North Carolina 629 /100k
6 Arkansas 602 /100k
7 Tennessee 589 /100k
8 Delaware 561 /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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dexmethylphenidate hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea201
Anxiety195
Headache188
Fatigue172
Abnormal Behaviour168
Feeling Abnormal166
Decreased Appetite158

Age at onset

Infant1
Child151
Adolescent78
Adult141
Elderly9

Reporter sex

0 reports
Male · 56%
Female · 41%
Unknown · 3%

Serious outcomes

Disabling73
Life-threatening65
Death36
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 303 118
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00527-8110-37 You're viewing this 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8110-37) 2018-10-09 Active

📄 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 💊 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
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION Dexmethylphenidate HCL extended-release capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate HCL extended-release capsules, 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 dexmethylphenidate HCL extended-release capsules, 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 dexmethylphenidate HCL extended-release capsules 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 ), Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.

Dexmethylphenidate HCl extended-release capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin XR, can result in overdose and death ( 5.1 , 9.2 , 10 ). Before prescribing dexmethylphenidate HCl extended-release capsules, 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 50 words ▾

1 INDICATIONS AND USAGE Dexmethylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate HCl extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2 ). Patients currently on methylphenidate: Dexmethylphenidate HCl extended-release capsules dosage is half (1/2) the current total daily dosage of methylphenidate ( 2.2 ). Patients currently on dexmethylphenidate immediate release tablets: Give the same daily dose of dexmethylphenidate HCl extended-release capsules ( 2.2 ).

Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients ( 2.2 ). Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults ( 2.2 ). Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ( 2.3 ).

2.1Pretreatment Screening Prior to treating patients with dexmethylphenidate HCl extended-release capsules, 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 before initiating dexmethylphenidate HCl extended-release capsules [ see Warnings and Precautions ( 5.10 )].

2.2Recommended Dosage Patients New to Methylphenidate The recommended starting dosage of dexmethylphenidate HCl extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate are: • Pediatric patients: Start with 5 mg orally once daily in the morning with or without food. • Adult patients: Start with 10 mg orally once daily in the morning with or without food. Patients Currently on Methylphenidate The recommended starting dose of dexmethylphenidate HCl extended-release capsules for patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate.

Patients currently using dexmethylphenidate immediate-release tablets may be given the same daily dose of dexmethylphenidate HCl extended-release capsules. Titration Schedule The dose may be titrated weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients. The dose should be individualized according to the needs and response of the patient.

Daily doses above 30 mg in pediatrics and 40 mg in adults have not been studied and are not recommended.

2.3Administration Instructions Dexmethylphenidate HCl extended-release capsules are administered orally and may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing.

The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

2.4Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinue dexmethylphenidate HCl extended-release capsules. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

💊 Dosage Forms and Strengths 140 words ▾

3 DOSAGE FORMS AND STRENGTHS • 5 mg extended-release capsules - blue opaque capsules (imprinted 106) • 10 mg extended-release capsules - clear capsules containing white to off-white beads (imprinted 107) • 15 mg extended-release capsules - light green opaque capsules (imprinted 108) • 20 mg extended-release capsules - white opaque capsules (imprinted 109) • 25 mg extended-release capsules - blue and white opaque capsules (imprinted 110) • 30 mg extended-release capsules - clear and white capsules containing white to off-white beads (imprinted 111) • 35 mg extended-release capsules - blue and clear capsules containing white to off-white beads (imprinted 112) • 40 mg extended-release capsules - light green and white opaque capsules (imprinted 113) Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg of dexmethylphenidate hydrochloride ( 3 ).

⛔ Contraindications 104 words ▾

4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of dexmethylphenidate HCl extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )] . Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )] .

Known hypersensitivity to methylphenidate or other components of dexmethylphenidate HCl extended-release capsules ( 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 dexmethylphenidate HCl extended-release capsules, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing dexmethylphenidate HCl extended-release capsules ( 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 dexmethylphenidate HCl extended-release capsules treatment.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ). Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted ( 5.7 ).

Acute Angle Closure Glaucoma : Dexmethylphenidate HCl extended-release capsules-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 dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules, 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 Dexmethylphenidate HCl extended-release capsules have a high potential for abuse and misuse. The use of dexmethylphenidate HCl extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules, 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 dexmethylphenidate HCl extended-release capsules, 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 dexmethylphenidate HCl extended-release capsules in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate HCl extended-release capsules to anyone else. Throughout dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules use in patients…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [ see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate HCl extended-release capsules [ see Contraindications ( 4 )] Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [ see Contraindications ( 4 ), Drug Interactions ( 7.1 )] Risks to Patients with Serious Cardiac Disease [ see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Heart Rate [ see Warnings and Precautions ( 5.3 )] Psychiatric Adverse Reactions [ see Warnings and Precautions ( 5.4 )] Priapism [ see Warnings and Precautions ( 5.5 )] Peripheral Vasculopathy, Including Raynaud’s Phenomenon [ see Warnings and Precautions ( 5.6 )] Long-Term Suppression of Growth in Pediatric Patients [ see Warnings and Precautions ( 5.7 )] Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.10 )] The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo): • Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety ( 6.1 ). • Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc at 1-844-834-0530, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Studies with Dexmethylphenidate HCl Extended-Release Capsules in Pediatric Patients with ADHD The safety data in this section is based on data from a 7-week controlled clinical study of dexmethylphenidate HCl extended-release capsules in 100 (103 randomized) pediatric patients with ADHD ages 6 to 17 years (ages 6 to 12, n = 86; ages 13 to 17, n = 17).

This study was a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the time of onset, duration of efficacy, tolerability, safety of dexmethylphenidate HCl extended-release capsules 5 mg to 30 mg/day who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD [ see Clinical Studies (14.1)] . Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): dyspepsia, decreased appetite, headache, and anxiety.

Adverse Reactions Leading to Discontinuation : 50 of 684 (7.3%) pediatric patients treated with dexmethylphenidate immediate-release tablets experienced an adverse reaction that resulted in discontinuation. The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each). Table 1 enumerates adverse reactions for the placebo-controlled, parallel-group study in children and adolescents with ADHD at flexible dexmethylphenidate HCl extended-release capsules doses of 5–30 mg/day.

The table includes only those events that occurred in 5% or more of patients treated with dexmethylphenidate HCl extended-release capsules and for which the incidence in patients treated with dexmethylphenidate HCl extended-release capsules was at least twice the incidence in placebo-treated patients. Table 1: Common Adverse Reactions in Pediatric Patients (6 to 17 years of age) With ADHD System organ class Adverse reaction Dexmethylphenidate HCl Extended-Release Capsules N = 53 Placebo N = 47 Gastrointestinal disorders Dyspepsia 38% 8% 19% 4% Metabolism and nutrition disorde…

🔄 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 Dexmethylphenidate HCl Extended-Release Capsules Table 5 presents clinically important drug interactions with dexmethylphenidate HCl extended-release capsules. Table 5: Clinically Important Drug Interactions With Dexmethylphenidate HCl Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical impact Concomitant use of MAOIs and CNS stimulants, including dexmethylphenidate HCl extended-release capsules, 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 dexmethylphenidate HCl extended-release capsules with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended- release capsules may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate.

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 during pregnancy ( see Clinical Considerations ). Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels.

A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels (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 dexmethylphenidate HCl extended-release capsules, 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, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed.

At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with 20 mg/day. Plasma levels in adults were comparatively similar to plasma levels in adolescents. Racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.

8.2Lactation Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. 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 stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate HCl extended-release capsul…

🤰 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 dexmethylphenidate HCl extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate.

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 during pregnancy ( see Clinical Considerations ). Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels.

A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels (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 dexmethylphenidate HCl extended-release capsules, 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, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed.

At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with 20 mg/day. Plasma levels in adults were comparatively similar to plasma levels in adolescents. Racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of dexmethylphenidate HCl extended-release capsules for the treatment of ADHD have been established in pediatric patients aged 6 to 17 years in two adequate and well-controlled clinical trials [ see Clinical Studies ( 14.2 )] . The safety and effectiveness of dexmethylphenidate HCl extended-release capsules in pediatric patients aged less than 6 years have not been established. The long-term efficacy of dexmethylphenidate HCl extended-release capsules in pediatric patients has not been established.

Long Term Suppression of Growth Growth should be monitored during treatment with stimulants, including dexmethylphenidate HCl extended-release capsules. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [ see Warnings and Precautions ( 5.7 )] . Juvenile Animal Toxicity Data Rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood.

A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 6 times the MRHD of 60 mg/day given to children on a mg/m2 basis. In a study conducted in young rats, racemic 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 to 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 of racemic methylphenidate 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 was 5 mg/kg/day (approximately 0.5 times 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 Dexmethylphenidate HCl extended-release capsules have not been studied in the geriatric population.

🆘 Overdosage 125 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. The pharmacokinetic profile of dexmethylphenidate HCl extended-release capsules should be considered when treating patients with overdose. 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 Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.

12.2Pharmacodynamics Dexmethylphenidate is the more pharmacologically active d -enantiomer of racemic methylphenidate. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Cardiac Electrophysiology At the recommended maximum total daily dosage of 40 mg, dexmethylphenidate HCl extended-release capsules do not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Absorption Dexmethylphenidate HCl extended-release capsules produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when orally administered to healthy adults. The initial rate of absorption for dexmethylphenidate HCl extended-release capsules is similar to that of dexmethylphenidate HCl immediate release tablets as shown by the similar rate parameters between the 2 formulations, i.e., first peak concentration (C max1 ), and time to the first peak (t max1 ), which is reached in 1.5 hours (typical range 1 to 4 hours).

The mean time to the interpeak minimum (t minip ) is slightly shorter, and time to the second peak (t max2 ) is slightly longer for dexmethylphenidate HCl extended-release capsules given once daily (about 6.5 hours; range, 4.5 to 7 hours) compared to dexmethylphenidate HCl immediate-release tablets given in 2 doses 4 hours apart (see Figure 1), although the ranges observed are greater for dexmethylphenidate HCl extended-release capsules. Dexmethylphenidate HCl extended-release capsules given once daily exhibits a lower second peak concentration (C max2 ), higher interpeak minimum concentrations (C minip ), and fewer peak and trough fluctuations than dexmethylphenidate immediate-release tablets given in 2 doses given 4 hours apart.

This is due to an earlier onset and more prolonged absorption from the delayed-release beads (see Figure 1). The ratio of geometric mean of AUC (0-inf) and C max after administration of dexmethylphenidate HCl extended-release capsules given once daily are 1.02 and 0.86 respectively, to the same total dose of dexmethylphenidate HCl immediate-release tablets given in 2 doses 4 hours apart. The variability in C max , C min , and AUC is similar between dexmethylphenidate HCl extended-release capsules and dexmethylphenidate HCl immediate-release tablets with approximately a 3-fold range in each.

Approximately 90% of the dose is absorbed after oral administration of radiolabeled racemic methylphenidate. However, due to first pass metabolism the mean absolute bioavailability of dexmethylphenidate when administered in various formulations was 22% to 25%. Figure 1.

Mean Dexmethylphenidate Plasma Concentration-Time Profiles After Administration 1 x 20 mg Dexmethylphenidate HCl Extended-Release Capsules (n = 24) and 2 x 10 mg Dexmethylphenidate HCl Immediate-Release Tablets (n = 25) After single dose administration, dexmethylphenidate HCl extended-release capsules demonstrated dose proportional pharmacokinetics (PK) in the range of 5 mg to 40 mg. For patients unable to swallow the capsule, the contents may be sprinkled on applesauce and administered [ see Dosage and Administration ( 2 )] .

Distribution The plasma protein binding of dexmethylphenidate is not known; racemic methylphenidate is bound to plasma proteins by 12% to 15%, independent of concentration. Dexmethylphenidate shows a volume of distribution of 2.65 ±

1.11L/kg. Elimination Plasma dexmethylphenidate concentrations decline monophasically following oral administration of dexmethylphenidate HCl extended-release capsules. The mean terminal elimination half-life of dexmethylphenidate was about 3 hours in healthy adults. Pediatric patients tend to have slightly shorter half-lives with means of 2 to 3 hours. Dexmethylphenidate was elim…

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.

📦 How Supplied / Storage and Handling 199 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dexmethylphenidate HCl extended-release capsules are available as follows: 5 mg extended-release capsules (NDC 0527-8106-37) are blue (imprinted 106), capsule-shaped and supplied in bottles of 100 10 mg extended-release capsules (NDC 0527-8107-37) are clear containing white to off-white beads (imprinted 107) supplied in bottles of 100 15 mg extended-release capsules (NDC 0527-8108-37) are light green (imprinted 108), capsule-shaped and supplied in bottles of 100 20 mg extended-release capsules (NDC 0527-8109-37) are white (imprinted 109), capsule-shaped and supplied in bottles of 100 25 mg extended-release capsules (NDC 0527-8110-37) are blue and white (imprinted 110), capsule-shaped and supplied in bottles of 100 30 mg extended-release capsules (NDC 0527-8111-37) are clear and white containing white to off-white beads (imprinted 111), capsule-shaped and supplied in bottles of 100 35 mg extended-release capsules (NDC 0527-8112-37) are blue and clear containing white to off-white beads (imprinted 112), capsule-shaped and supplied in bottles of 100 40 mg extended-release capsules (NDC 0527-8113-37) are light green and white (imprinted 113), capsule-shaped and supplied in bottles of 100 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Dispense in tight container (USP).

📋 Description ~1 min read ▾

11 DESCRIPTION Dexmethylphenidate HCl extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate HCl extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile.

Each bead-filled dexmethylphenidate HCl extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate HCl extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-.

Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note*=asymmetric carbon center Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus.

It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients : ammonio methacrylate copolymer, D&C Red #28 (5 mg, 10 mg, 25 mg and 35 mg strengths), edible printing ink Red SB-1010N containing Shellac NF and Carmine Powder Red, FD&C Blue #1 (5 mg, 15 mg, 25 mg, 35 mg and 40 mg strengths), FDA/E172 Yellow Iron Oxide (15 mg and 40 mg strengths), gelatin, methacrylic acid copolymer, Opadry Clear containing hypromellose and polyethylene glycol, povidone, sugar spheres containing corn starch as well as sugar syrup and sucrose derived from sugar cane, talc, titanium dioxide, and triethyl citrate.

Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients 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 Focalin XR, 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 dexmethylphenidate HCl extended-release capsules in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules can cause elevations of their blood pressure and pulse rate [ see Warnings and Precautions ( 5.3 )] .

Psychiatric Adverse Reactions Advise patients that dexmethylphenidate HCl extended-release capsules, 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 them 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 beginning treatment with dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules. 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 dexmethylphenidate HCl extended-release capsules may cause slowing of growth and weight loss [ see Warnings and Precautions ( 5.7 )] .

Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with dexmethylphenidate HCl extended-release capsules [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 dexmethylphenidate HCl extended-release capsules. 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 Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including dexmethylphenidate HCl extended-release capsules, during pregnancy [ see Use in Specific Populations ( 8.1 )] . Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB72006C Rev.

09/2025

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Dexmethylphenidate Hydrochloride (Dex-meth-ill-FEN- ĭ -date Hī-dro-KLOR-īd) extended-release capsules for oral use, CII What is the most important information I should know about dexmethylphenidate HCl extended-release capsules? Dexmethylphenidate HCl extended-release capsules may cause serious side effects, including: Abuse, misuse, and addiction. Dexmethylphenidate HCl extended-release capsules have a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of dexmethylphenidate HCl extended-release capsules, 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 dexmethylphenidate HCl extended-release capsules 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 dexmethylphenidate HCl extended-release capsules and will monitor you or your child during treatment.

Dexmethylphenidate HCl extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give dexmethylphenidate HCl extended-release capsules to anyone else. See “What is dexmethylphenidate HCl extended-release capsules?” for more information.

Keep dexmethylphenidate HCl extended-release capsules in a safe place and properly dispose of any unused medicine. See “How should I store dexmethylphenidate HCl extended-release capsules?” 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 dexmethylphenidate HCl extended-release capsules.

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 has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking dexmethylphenidate HCl extended-release capsules. Increased blood pressure and heart rate.

Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate HCl extended-release capsules. Mental (psychiatric) problems: All Patients onew or worse behavior and thought problems onew or worse bipolar illness onew 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 dexmethylphenidate HCl extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What are dexmethylphenidate HCl extended-release capsules? Dexmethylphenidate HCl extended-release capsules are a central nervous system stimulant (CNS) prescription medicine.

It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) . Dexmethylphenidate HCl extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Dexmethylphenidate HCl extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dexmethylphenidate HCl extended-release capsules are a federally controlled substance (CII) becau…

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.