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Dexmethylphenidate Hydrochloride 10 mg Tablet, 30-count — NDC 43386-0861-03 package photo

Dexmethylphenidate Hydrochloride 10 mg Tablet, 30-count

by Lupin Pharmaceuticals,Inc. · 30 TABLET in 1 BOTTLE (43386-861-03)
NDC 43386-0861-03
🏷️ FDA NDC (as labeled) 43386-861-03 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also comes in: 100 tablets 43386-0861-01 1000 tablets 43386-0861-10
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) 43386-861-03
Product NDC 43386-861
11-digit billing NDC 43386086103
RxCUI 899518, 899548, 899557
UNII 1678OK0E08
Application # ANDA204534
SPL Set ID a61932ef-c2b6-4363-a21d-1f0358f317b6
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 2015-12-04
Route ORAL
Dosage form TABLET
Substance DEXMETHYLPHENIDATE HYDROCHLORIDE
GPI-14 61400016100340
GPI class Dexmethylphenidate HCl
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 43386-861-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0861-03. 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

LabelerLupin Pharmaceuticals,Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA204534 (ANDA)
Labeler code43386
First marketedDec 2015
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio89 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 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 / Yellow / White
ShapeRound
Imprint861;n
Size7 mm
ScoringNot scored
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the 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.

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

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

Inactive ingredient FAQ

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

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets 1000 tablets
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 10 mg 10702-0108-01 KVK-TECH, 100 tablets $0.339 AB Availability likely —
Dexmethylphenidate Hydrochloride 10 mg 27808-0093-01 Cranbury 100 tablets $0.339 AB Availability likely —
Dexmethylphenidate Hydrochloride 10 mg 67877-0657-01 Ascend 100 tablets $0.339 AB Availability likely —
Dexmethylphenidate hydrochloride 10 mg 75834-0328-01 Nivagen 100 tablets $0.339 AB Availability likely —
Focalin 10 mg 00078-0382-05 Novartis 100 tablets $1.330 AB Discontinued —
Focalin 10 mg 66758-0252-01 Sandoz 100 tablets $1.330 AB Availability likely —
Dexmethylphenidate Hydrochloride 10 mgthis 43386-0861-03 Lupin 30 tablets — AB FDA listed —
Dexmethylphenidate Hydrochloride 10 mg 55466-0123-12 Neolpharma, 100 tablets — AB Discontinued —
Dexmethylphenidate hydrochloride 10 mg 57664-0379-08 Sun 100 tablets — AB FDA listed —
Dexmethylphenidate Hydrochloride 10 mg 63629-2307-01 Bryant 100 tablets — AB FDA listed —
Dexmethylphenidate Hydrochloride 10 mg 72162-1286-01 Bryant 100 tablets — AB FDA listed —
Dexmethylphenidate hydrochloride 10 mg 72162-2427-01 Bryant 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Dec 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
43386-0861-01 100 TABLET in 1 BOTTLE (43386-861-01) $0.2608 / ea $26.08 2015-12-04 Active
43386-0861-03 You're viewing this 30 TABLET in 1 BOTTLE (43386-861-03) — — 2015-12-04 Active
43386-0861-10 1000 TABLET in 1 BOTTLE (43386-861-10) — — 2015-12-04 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 43386-0861-03?
NDC 43386-0861-03 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 43386-0861-03 and NDC 43386-0861-01?
Both are Dexmethylphenidate Hydrochloride 10 mg Tablet — the drug itself is identical. NDC 43386-0861-03 is the 30-count package, while NDC 43386-0861-01 is the 100 tablets package.
What NDC number is used to bill for this package of Dexmethylphenidate Hydrochloride 10 mg Tablet?
Bill NDC 43386-0861-03 — the 11-digit billing format is 43386086103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43386-861-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43386-0861-03, written without dashes as 43386086103. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43386-0861-03, the first segment (43386) is the labeler code FDA assigned to Lupin Pharmaceuticals,Inc.; the middle segment (0861) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 100 tablets (43386-0861-01), 1000 tablets (43386-0861-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Lupin Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE AND DEPENDENCE Dexmethylphenidate hydrochloride tablets has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride tablets, can result in overdose and death [see Overdosage (10) ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dexmethylphenidate hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dexmethylphenidate hydrochloride tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2) ]. WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning.

Dexmethylphenidate hydrochloride tablets has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing dexmethylphenidate hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.

Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride tablet is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Dexmethylphenidate hydrochloride is 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 Administer orally twice daily, 4 hours apart with or without food ( 2 ) For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily) (2.2). For patients currently taking methylphenidate: Initiate dexmethylphenidate hydrochloride therapy with half (1/2) the current total daily dose of methylphenidate ( 2.2 ). Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) ( 2.2 ).

2.1Pretreatment Screening Prior to treating patients with dexmethylphenidate hydrochloride tablets, 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 hydrochloride tablets [ see Warnings and Precautions (5.10)] .

2.2Pediatric Patients with Attention Deficit Hyperactivity Disorder Patients New to Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride tablet for pediatric patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg daily (2.5 mg twice daily) with or without food. Patients Currently on Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride tablet for pediatric patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate.

Titration Schedule The dose may be titrated weekly in increments of 2.5 to 5 mg to a maximum of 20 mg daily (10 mg twice daily). The dose should be individualized according to the needs and response of the patient. Maintenance/Extended Treatment Pharmacological treatment of ADHD may be needed for extended periods.

Periodically reevaluate the long-term use of dexmethylphenidate hydrochloride tablets and adjust dosage as needed.

2.3Administration Instructions Dexmethylphenidate hydrochloride tablets is administered orally twice daily, at least 4 hours apart.

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

💊 Dosage Forms and Strengths 85 words ▾

3 DOSAGE FORMS AND STRENGTHS Dexmethylphenidate hydrochloride tablets are as follows: • 2.5 mg: blue, round, flat-faced, beveled-edge tablets, debossed with “862” on the one side and “n” on the other side • 5 mg: yellow, round, flat-faced, beveled-edge tablets, debossed with “860” on the one side and “n” on the other side • 10 mg: white, round, flat-faced, beveled-edge tablets, debossed with “861” on the one side and “n” on the other side Tablets: 2.5 mg, 5 mg, and 10 mg ( 3 )

⛔ Contraindications 102 words ▾

4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets. 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 hydrochloride tablets ( 4 ). Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risks to Patient 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 hydrochloride tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing dexmethylphenidate hydrochloride tablets ( 5.4 ). Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ).

Peripheral Vasculopathy, including Raynaud’s Phenomenon : Careful observation for digital changes is necessary during dexmethylphenidate hydrochloride tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy (5.6) . Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients.

Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted (5.7) . Acute Angle Closure Glaucoma : dexmethylphenidate hydrochloride tablets -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist ( 5.8 ) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe dexmethylphenidate hydrochloride tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.

Closely monitor patients with a history of increased IOP or open angle glaucoma ( 5.9 ). Motor and Verbal Tics, and Worsening of Tourette’s Syndrome : Before initiating dexmethylphenidate hydrochloride tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome.

Discontinue treatment if clinically appropriate ( 5.10 ).

5.1Potential for Abuse and Dependence Dexmethylphenidate hydrochloride tablet has a high potential for abuse and misuse. The use of dexmethylphenidate hydrochloride tablet exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dexmethylphenidate hydrochloride tablet 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 hydrochloride tablet, 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 hydrochloride tablet 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 hydrochloride tablet in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate hydrochloride tablet to anyone else. Throughout dexmethylphenidate hydrochloride tablet 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 Patient 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 hydrochloride tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other seriou…

🤒 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 hydrochloride tablet [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) in pediatric patients 6 to 17 years were abdominal pain, fever, nausea, and anorexia ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 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. Clinical Trials Experience with Dexmethylphenidate Hydrochloride in Pediatric Patients with ADHD The safety data in this section is based on data related to dexmethylphenidate hydrochloride exposure during the premarketing development program in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects).

These participants received dexmethylphenidate hydrochloride 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in 2 controlled clinical studies, 2 clinical pharmacology studies, and 2 open-label long-term safety studies. Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): abdominal pain, fever, anorexia, and nausea Adverse Reactions Leading to Discontinuation: Overall, 50 of 684 (7.3%) pediatric patients treated with dexmethylphenidate hydrochloride 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 two, placebo-controlled, parallel group studies in pediatric patients with ADHD taking dexmethylphenidate hydrochloride tablet doses of 5, 10, and 20 mg/day. The table includes only those reactions that occurred in patients treated with dexmethylphenidate hydrochloride tablet for which the incidence was at least 5% and twice the incidence among placebo-treated patients.

Table 1: Common Adverse Reactions in Pediatric Patients (6 to 17 years of age) with ADHD* System Organ Class Adverse Reactions Dexmethylphenidate hydrochloride tablets (N = 79) Placebo (N = 82) Body as a Whole Abdominal pain 15% 6% Fever 5% 1% Digestive System Anorexia 6% 1% Nausea 9% 1% Abbreviation: ADHD, attention deficit hyperactivity disorder

6.2Postmarketing Experience The following additional adverse reactions have been identified during post approval use of dexmethylphenidate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or est…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). Halogenated Anesthetics: Avoid use of dexmethylphenidate hydrochloride tablets on the day of surgery if halogenated anesthetics will be used ( 7.1 ).

7.1Clinically Important Drug Interactions with Dexmethylphenidate Hydrochloride Tablet Table 2 presents clinically important drug interactions with dexmethylphenidate hydrochloride tablet. Table 2: Clinically Important Drug Interactions with Dexmethylphenidate Hydrochloride Tablet Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including dexmethylphenidate hydrochloride , can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4)] .

Intervention Concomitant use of dexmethylphenidate hydrochloride with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical Impact Dexmethylphenidate hydrochloride may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions (5.3)] . Intervention Adjust the dosage of the antihypertensive drug as needed.

Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and dexmethylphenidate hydrochloride may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Monitor blood pressure and avoid use of dexmethylphenidate hydrochloride 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 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 use 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. Plasma levels in adults were comparatively similar to plasma levels in adolescents (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants such as dexmethylphenidate hydrochloride, 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 the MRHD of 20 mg/day.

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 hydrochloride and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

8.4Pediatric Use The safety and effectiveness of dexmethylphenidate hydrochloride have been established in pediatric patients ages 6 to 17 years in two…

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

12.2Pharmacodynamics Pharmacodynamics 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 A formal QT study has not been conducted in patients taking dexmethylphenidate hydrochloride tablet; however, a large QT effect is not expected.

At the recommended maximum total daily dosage of 40 mg, dexmethylphenidate hydrochloride extended-release capsule does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Absorption Dexmethylphenidate hydrochloride is readily absorbed following oral administration of dexmethylphenidate hydrochloride. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1.5 hours postdose. No differences in the pharmacokinetics of dexmethylphenidate hydrochloride were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD.

After single dose administration of dexmethylphenidate hydrochloride to pediatric patients, dexmethylphenidate exposure (C max and AUC 0-inf ) showed dose-proportional increase in the range of 2.5 mg to 10 mg. Comparable plasma dexmethylphenidate levels were achieved following single dl-threo -methylphenidate HCl doses given as capsules in twice the total mg amount (equimolar with respect to dexmethylphenidate hydrochloride). 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%. Effect of Food High fat breakfast did not significantly affect C max or AUC 0-inf of dexmethylphenidate when two 10 mg dexmethylphenidate hydrochloride tablets were administered, but delayed T max from 1.5 hours post dose to 2.9 hours post dose. 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 declined exponentially following oral administration of dexmethylphenidate hydrochloride tablets. Intravenous dexmethylphenidate was eliminated with a mean clearance of 0.40 ±

0.12L/hr/kg. The mean terminal elimination half-life of dexmethylphenidate was approximately 2.2 hours. Metabolism In humans, dexmethylphenidate is metabolized primarily via de-esterification to d -α-phenyl-piperidine acetic acid (also known as d -ritalinic acid).

This metabolite has little or no pharmacological activity. There is little or no in vivo interconversion to the l - threo -enantiomer. Excretion After oral dosing of radiolabeled racemic methylphenidate in humans, about 90% of the radioactivity was recovered in urine.

The main urinary metabolite of racemic dl -methylphenidate was dl -ritalinic acid, accountable for approximately 80% of the dose. Urinary excretion of parent compound accounted for 0.5% of an intravenous dose. Studies in Special Populations Male and Female Patients Pharmacokinetic parameters were similar for boys and girls (mean age 10 years).

In a single dose study conducted in adults, the mean dexmethylphenidate AUC 0-inf values (adjusted for body weight) following single two 10 mg doses of dexmethylphenidate hydrochloride were 25% to 35% higher in adult female volunteers (n = 6) compared to male volunteers (n = 9). Both T max and t 1/2 were comparable for males and females. Racial or Ethnic Groups There is insu…

🧬 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 133 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets: blue, round, flat-faced, beveled-edge tablets, debossed with “862” on the one side and “n” on the other side. Bottles of 30…………………………NDC 43386-862-03 Bottles of 100...................NDC 43386-862-01 Bottles of 1000….…………………NDC 43386-862-10 5 mg Tablets: yellow, round, flat-faced, beveled-edge tablets, debossed with “860” on the one side and “n” on the other side. Bottles of 30…………………………NDC 43386-860-03 Bottles of 100.....................NDC 43386-860-01 Bottles of 1000………………………NDC 43386-860-10 10 mg Tablets: white, round, flat-faced, beveled-edge tablets, debossed with “861” on the one side and “n” on the other side.

Bottles of 30……………………………NDC 43386-861-03 Bottles of 100....................NDC 43386-861-01 Bottles of 1000…………………………NDC 43386-861-10 Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP).

📋 Description 143 words ▾

11 DESCRIPTION Dexmethylphenidate hydrochloride tablets contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride tablets are available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration.

Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its structural formula is: C 14 H 19 NO 2 •HCl M.W. 269.77 g/mol Note: * = asymmetric carbon centers Dexmethylphenidate hydrochloride is a white crystalline powder.

Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol.

Inactive ingredients: citric acid anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, and FD&C Blue No.1 (2.5 mg tablets), D&C Yellow #10 (5 mg tablets); the 10 mg tablet contains no dye. structure

💬 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 dexmethylphenidate hydrochloride tablets, 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 hydrochloride tablets in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate hydrochloride tablets to anyone else.

Risks to Patient with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with dexmethylphenidate hydrochloride tablets 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 hydrochloride tablet can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions ( 5.3 )].

Psychiatric Adverse Reactions Advise patients that dexmethylphenidate hydrochloride tablet, 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 hydrochloride tablet 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 hydrochloride tablet. 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 hydrochloride tablet 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 hydrochloride tablet [ 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 hydrochloride tablet. 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 ) ].

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 SAP code: 274932 Rev: 11/2023

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Dexmethylphenidate ( dex'' meth il fen' i date) Hydrochloride (hye''droe klor' ide) Tablets CII What is the most important information I should know about dexmethylphenidate hydrochloride tablet? Dexmethylphenidate hydrochloride tablet may cause serious side effects, including: Abuse, misuse, and addiction. Dexmethylphenidate hydrochloride tablet has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of dexmethylphenidate hydrochloride tablet, 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 hydrochloride tablet 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 hydrochloride tablet and will monitor you or your child during treatment. dexmethylphenidate hydrochloride tablet may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.

Do not give dexmethylphenidate hydrochloride tablet to anyone else. See “ What is dexmethylphenidate hydrochloride tablet? ” for more information. o Keep dexmethylphenidate hydrochloride tablet in a safe place and properly dispose of any unused medicine. See “ How should I store dexmethylphenidate hydrochloride tablet? ” for more information. o 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 hydrochloride tablet. 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 hydrochloride tablet. • 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 hydrochloride tablet. • Mental (psychiatric) problems: All Patients o new or worse behavior and thought problems o new or worse bipolar illness o new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking dexmethylphenidate hydrochloride tablet, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What are dexmethylphenidate hydrochloride tablets? Dexmethylphenidate hydrochloride tablets are a central nervous system stimulant (CNS) prescription medicine.

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

Who should not take dexmethylphenidate hydrochloride tablets: Dexmethylphenidate hydrochloride tablets should not be taken if you or your child: are allergic to methylphenidate hydrochloride, or any of the ingredients in dexmethylphenidate hydrochloride tablets. See the…

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.