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Quillivant XR methylphenidate hydrochloride 600 mg/120mL Suspension, Extended Release — NDC 24478-0322-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Quillivant XR methylphenidate hydrochloride 600 mg/120mL Suspension, Extended Release — NDC 24478-322-04 (Billing 24478-0322-04)

by NextWave Pharmaceuticals, Inc · 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

This is a package of Quillivant XR methylphenidate hydrochloride 600 mg/120mL Suspension, Extended Release from NextWave Pharmaceuticals, Inc, no longer marketed (first marketed Oct 2012), no longer in the FDA NDC Directory; retail pharmacies pay about $2.70 per mL (NADAC). It is this product's only package size.

NDC 24478-0322-04
🏷️ FDA NDC (as labeled) 24478-322-04 billing pads the product segment with a zero
Rx only Brand Discontinued CII ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 24478-322-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24478 labeler · 322 product · 04 package
Package marketed since
Oct 1, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 2447832204 5
Medicaid fills, this package
82,165 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 7, 2022 — Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind. (RISING PHARMACEUTICALS) · FDA recall D-0573-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2018. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24478-322-04
Product NDC 24478-322
11-digit billing NDC 24478032204
NCPDP billing unit ML — per mL (volume)
RxCUI 1312583, 1312589
UNII 4B3SC438HI
Application # NDA202100
SPL Set ID c2dc2109-44a6-4797-b04e-18761dd9d45a
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2018)
Marketing start 2012-10-01
Route ORAL
Dosage form SUSPENSION, EXTENDED RELEASE
Substance METHYLPHENIDATE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 6140002010G220
GPI class Quillivant XR
GCN Seq No 070374
GCN 33887
HICL code 001682
Ingredient (HICL) Methylphenidate Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2V
Therapeutic class — specific (HIC3) Tx For Attention Deficit-Hyperact(Adhd)/Narcolepsy
AHFS code 28:20.32.00
AHFS class Respiratory And Cns Stimulants
FDB label name QUILLIVANT XR 25 MG/5 ML SUSP
FDB brand name Quillivant Xr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 070374
  • GCN: 33887
  • GPI-14 (Medi-Span): 6140002010G220
  • HICL (First Databank): 001682
  • AHFS class code: 28:20.32.00
  • RxCUI (RxNorm): 1312583
Why two NDCs? The FDA registers this code as 24478-322-04 — 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 → 24478-0322-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

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

Clinical

Label name QUILLIVANT XR 25 MG/5 ML SUSP Ingredient Methylphenidate Hcl
📖 What it is MedlinePlus · NLM

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

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $2.701 $324.11 / 120 ml
Medicaid paysCMS SDUD · 12 mo $2.73 $327.67 / 120 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Jan 2026 May 2026 Sep 2026 $2.718 $2.701
▼ Down 1% over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24478-0322-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE 2012-10-01 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quillivant XR 900 mg/180mL 24478-0324-06 NextWave 1 bottle $1.801 AB Discontinued save 33%
Quillivant XR 750 mg/150mL 24478-0323-05 NextWave 1 bottle $2.161 AB Discontinued save 20%
Quillivant XR 600 mg/120mLthis 24478-0322-04 NextWave 1 bottle $2.701 AB Discontinued —
Quillivant XR 300 mg/60mL 24478-0321-02 NextWave 1 bottle $5.396 AB Discontinued +100%
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2012
First FDA approval
Sep 2012
📍
2026
Currently FDA-listed
14 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 27, 2012 AB TE-rated RLD RS ⏳ ~4.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8465765 — method of use (U-1415)
US 8778390 — method of use (U-1543)
US 8956649 — method of use (U-1665)
US 8563033 — method of use (U-1415)
US 9040083 — drug product
US 8062667 — drug product
US 8287903 — drug product
2012 2014 2016 2018 2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (7)
PatentTypeUse codeExpires
US 8465765 ↗ Method of use U-1415 Feb 15, 2031
US 8778390 ↗ Method of use U-1543 Feb 15, 2031
US 8956649 ↗ Method of use U-1665 Feb 15, 2031
US 8563033 ↗ Method of use U-1415 Feb 15, 2031
US 9040083 ↗ Drug product — Feb 15, 2031
US 8062667 ↗ Drug product — Mar 29, 2029
US 8287903 ↗ Drug product — Feb 15, 2031
Common questions
Is there a generic version of QUILLIVANT XR 25 MG/5 ML SUSP?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for QUILLIVANT XR 25 MG/5 ML SUSP. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

FlavorBanana
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.

🧪 Avoiding an ingredient? See Methylphenidate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • UNII 58QVG85GW3
    A synthetic polymer made from vinyl acetate and phthalic acid. It coats tablets and capsules to control when and where the medicine dissolves in the digestive system, protecting the contents from stomach acid.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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 XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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.

Manufacturer & labeler

LabelerNextWave Pharmaceuticals, Inc
Application holderNEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA INC
FDA applicationNDA202100 (NDA)
Labeler code24478
First marketedOct 2012
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio13 products on file

More NDCs from NextWave Pharmaceuticals, Inc labeler code 24478

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION QUILLIVANT XR 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 QUILLIVANT XR, 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 QUILLIVANT XR, 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 QUILLIVANT XR 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.

QUILLIVANT XR 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 QUILLIVANT XR, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing QUILLIVANT XR, 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 157 words ▾

1 INDICATIONS AND USAGE QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. Limitations of Use The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. QUILLIVANT XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

( 1 ) Limitations of Use The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Before administering the dose, vigorously shake bottle for at least 10 seconds. ( 2.2 ) May be taken with or without food. ( 2.3 ) For patients 6 years and above, recommended starting dose is 20 mg given orally once daily in the morning.

Dosage may be increased weekly in increments of 10 mg to 20 mg per day. Daily dosage above 60 mg is not recommended. ( 2.2 ) Reconstitution instructions for the pharmacist: Tap bottle until powder flows freely.

Remove bottle cap, add specified amount of water for reconstitution. Insert bottle adapter into neck of bottle. Replace bottle cap.

Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension. ( 2.6 )

2.1Pretreatment Screening Prior to treating patients with QUILLIVANT XR, 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 QUILLIVANT XR [see Warnings and Precautions (5.10) ].

2.2Recommended Dosage Before administering the dose, VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least 10 seconds, to ensure that the proper dose is administered. The recommended starting dose of QUILLIVANT XR for patients 6 years and above is 20 mg once daily in the morning. The dose may be titrated weekly in increments of 10 mg to 20 mg.

Daily doses above 60 mg have not been studied and are not recommended. As with any CNS stimulant, during titration of QUILLIVANT XR, the prescribed dose should be adjusted, if necessary, until a well‑tolerated, therapeutic dose is achieved. Patients should be advised to avoid alcohol while taking QUILLIVANT XR [see Clinical Pharmacology (12.3) ].

2.3Administration Instructions QUILLIVANT XR should be orally administered once daily in the morning with or without food [see Clinical Pharmacology ( 12.3 ) ].

2.4Switching from other Methylphenidate Products If switching from other methylphenidate products, discontinue that treatment, and titrate with QUILLIVANT XR using the above titration schedule. Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles [see Description ( 11 ) , Clinical Pharmacology ( 12.3 ) ].

2.5Dose Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

2.6Reconstitution Instructions for the Pharmacist QUILLIVANT XR is supplied as a powder for oral suspension which must be reconstituted with water prior to dispensing. Preparation instructions: Tap bottle until powder flows freely. Remove bottle cap, and add specified amount of water to the bottle (see Table 1 below).

Fully insert bottle adapter into neck of bottle [see Instructions for Use , Figures F and G] . Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension.

Table 1: Product Reconstitution Instructions Amount of drug in bottle Amount of water to add to bottle Final reconstituted volume (yield) 300 mg 53 mL 60 mL 600 mg 105 mL 120 mL 750 mg 131 mL 150 mL 900 mg 158 mL 180 mL Store reconstituted QUILLIVANT XR at 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF). Dispense in original packaging (bottle in carton) with bottle adapter inserted and with enclosed oral dosing dispenser. QUILLIVANT XR is stable for up to 4 months after reconstitution.

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release oral suspension (after reconstitution with water): equivalent of 25 mg of methylphenidate hydrochloride per 5 mL. Extended-release oral suspension (after reconstitution with water): equivalent of 25 mg of methylphenidate hydrochloride per 5 mL ( 3 )

⛔ Contraindications 132 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to methylphenidate or product components. ( 4.1 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. ( 4.2 , 7.1 )

4.1Hypersensitivity to Methylphenidate or other Components of QUILLIVANT XR QUILLIVANT XR is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of QUILLIVANT XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions ( 6.2 ) ].

4.2Monoamine Oxidase Inhibitors QUILLIVANT XR is contraindicated during treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI), because of the risk of hypertensive crisis [see Drug Interactions ( 7.1 ) ].

⚠️ 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 QUILLIVANT XR, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing QUILLIVANT XR. ( 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 QUILLIVANT XR 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 : QUILLIVANT XR -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 QUILLIVANT XR 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 QUILLIVANT XR, 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 QUILLIVANT XR has a high potential for abuse and misuse. The use of QUILLIVANT XR exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. QUILLIVANT XR 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 QUILLIVANT XR, 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 QUILLIVANT XR, 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 QUILLIVANT XR in a safe place, preferably locked, and instruct patients to not give QUILLIVANT XR to anyone else. Throughout QUILLIVANT XR 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 occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid QUILLIVANT XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease.

5.3Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases. Monitor all QUILLIVANT XR-treated patients for hypertension and tachycardia.

5.4Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis C… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Known hypersensitivity to methylphenidate products or other ingredients of QUILLIVANT XR [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2 , 9.3 )] 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) ] Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 732-940-0358 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 Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Adverse Reactions in Studies with QUILLIVANT XR in Children and Adolescents with ADHD There is limited experience with QUILLIVANT XR in controlled trials. Based on this limited experience, the adverse reaction profile of QUILLIVANT XR appears similar to other methylphenidate extended-release products. The most common (≥2% in the QUILLIVANT XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6 to 12 years) were affect lability, excoriation, initial insomnia, tic, decreased appetite, vomiting, motion sickness, eye pain, and rash.

Table 2: Common Adverse Reactions occurring in ≥2% of subjects on QUILLIVANT XR and greater than placebo during the controlled cross-over phase Adverse reaction QUILLIVANT XR N= 45 Placebo N= 45 Affect lability 9% 2% Excoriation 4% 0 Initial Insomnia 2% 0 Tic 2% 0 Decreased appetite 2% 0 Vomiting 2% 0 Motion sickness 2% 0 Eye pain 2% 0 Rash 2% 0

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows: Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic p… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 186 words ▾

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

7.1Clinically Important Drug Interactions MAOI Inhibitors Do not administer QUILLIVANT XR concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment. Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.

Antihypertensive Drugs QUILLIVANT XR may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the hypertensive drug as needed [see Warnings and Precautions (5.3) ]. Halogenated Anesthetics Concomitant use of halogenated anesthetics and QUILLIVANT XR may increase the risk of sudden blood pressure and heart rate increase during surgery.

Monitor blood pressure and avoid use of QUILLIVANT XR in patients being treated with anesthetics on the day of surgery. Risperidone Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

👥 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 during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ . Risk Summary There are limited published studies and small case series that report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks.

There are clinical considerations [see Clinical Considerations ] . No teratogenic effects were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses 2 and 11 times, respectively, the maximum recommended human dose (MRHD). However, spina bifida was observed in rabbits at a dose 40 times the MRHD [see Data ].

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 stimulant medications, such as QUILLIVANT XR, 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 studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m 2 basis).

There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m 2 basis).

8.2Lactation Risk Summary Limited published literature 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 CNS stimulant exposure are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QUILLIVANT XR and any potential adverse effects on the breastfed infant from QUILLIVANT XR 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 QUILLIVANT XR have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

The safety and effectiveness of QUILLIVANT XR have been established in pediatric patients ages 6 to 17 years. Use of QUILLIVANT XR in pediatric patients 6 to 12 years of age is supported by on… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ . Risk Summary There are limited published studies and small case series that report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks.

There are clinical considerations [see Clinical Considerations ] . No teratogenic effects were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses 2 and 11 times, respectively, the maximum recommended human dose (MRHD). However, spina bifida was observed in rabbits at a dose 40 times the MRHD [see Data ].

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 stimulant medications, such as QUILLIVANT XR, 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 studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m 2 basis).

There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m 2 basis).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of QUILLIVANT XR have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

The safety and effectiveness of QUILLIVANT XR have been established in pediatric patients ages 6 to 17 years. Use of QUILLIVANT XR in pediatric patients 6 to 12 years of age is supported by one adequate and well-controlled study [see Clinical Studies (14) ]. Use in 12 to 17 year old’s is supported by the adequate and well-controlled studies of QUILLIVANT XR in younger pediatric patients and additional pharmacokinetic data in adolescents, along with safety information from other methylphenidate‑containing products.

Long Term Suppression of Growth Growth should be monitored during treatment with CNS stimulants, including QUILLIVANT XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7) ]. Juvenile Animal Data Rats treated with 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 maximum recommended human dose (MRHD) on a mg/m 2 basis. In the study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10).

When these animals were tested as adults (postnatal weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was observed in females exposed to the highest dose (12 times the MRHD on a mg/m 2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m 2 basis).

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

🧓 Geriatric Use 17 words ▾

8.5Geriatric Use QUILLIVANT XR has not been studied in patients over the age of 65 years.

🆘 Overdosage 123 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 QUILLIVANT XR 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 Methylphenidate is a central nervous system (CNS) stimulant.

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l- isomers. The d- isomer is more pharmacologically active than the l ‑ isomer. The mode of therapeutic action in ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

12.3Pharmacokinetics Absorption Following a single, 60 mg oral dose of QUILLIVANT XR in 28 healthy adult subjects in a crossover study under fasting conditions, d- methylphenidate ( d- MPH) mean (± SD) peak plasma concentrations of 13.6 (± 5.8) ng/mL occurred at a median time of 5 hours after dosing (Figure 2). The relative bioavailability of QUILLIVANT XR compared to Methylphenidate IR oral solution (2x30 mg, q6h) is 95%. Figure 2: Mean d- Methylphenidate Plasma Concentration-Time Profiles The single dose pharmacokinetics of d- MPH under fed conditions are summarized (Table 3) from studies in children and adolescents with ADHD, and healthy adults following an oral dose of 60 mg QUILLIVANT XR.

Table 3: d-MPH PK Parameters (mean ±SD) after 60 mg oral dosing of QUILLIVANT XR* PK Parameter Children† (n=3) Adolescent† (n=4) Adult (n=27) T max (hr) ‡ 4.05 (3.98-6.0) 2.0 (1.98-4.0) 4.0 (1.3-7.3) T 1/2 (hr) 5.2±0.1 5.0±0.2 5.2±1.0 C max (ng/mL) 34.4±14.0 21.1±5.9 17.0±7.7 AUC inf (hr*ng/mL) 378±175 178±54.2 163.2±80.3 Cl (L/hr/kg) 4.27±0.70 5.06±1.42 5.66±2.15 * Breakfast was given 30 min prior to drug administration † total MPH measured in children (9 to 12 years old) and adolescents (13 to 15 years old), l- MPH <2% of d- MPH in circulation ‡ data presented as median (range) Food Effects In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of QUILLIVANT XR at a dose of 60 mg, the presence of food reduced the time to peak concentration by approximately 1 hour (fed: 4 hours vs. fasted: 5 hours).

Overall, a high-fat meal increased the average C max of QUILLIVANT XR by about 28% and the AUC by about 19%. These changes are not considered clinically significant. Elimination Following a single 60 mg oral dose of QUILLIVANT XR in 28 healthy adult subjects under fasting conditions, the mean plasma terminal elimination half-life of d- methylphenidate was 5.6 (± 0.8) hours.

Metabolism In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenyl-piperidine acetic acid (PPAA). The metabolite has little or no pharmacologic activity. Excretion After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine.

The main urinary metabolite was PPAA, accounting for approximately 80% of the dose. Alcohol Effect An in vitro study was conducted to explore the effect of alcohol on the release characteristics of methylphenidate from QUILLIVANT XR Oral Suspension. At alcohol concentrations of 5% and 10%, there was no effect of alcohol on the release characteristics of methylphenidate.

At 20% alcohol concentration, there was on average a 20% increase in drug exposure [see Dosage and Administration ( 2.2 ) ]. Specific Populations Sex There is insufficient experience with the use of QUILLIVANT XR to detect gender variations in pharmacokinetics. Race There is insufficient experience with the use of QUILLIVANT XR to detect ethnic variations in pharmacokinetics.

Age The pharmacokinetics of methylphenidate after QUILLIVANT XR administration were studied in pediatric patients with ADHD between 9 and 15 years of age. After a single oral dose of 60 mg QUILLIVANT XR, plasma concentrations of methylphenidate in children (9 to 12 years old; n=3) were approximately twice the concentrations observed in adults. The plasma concentrations in adolescent patients (13 to 15 years old; n=4) were similar to those in adults.

Renal Impairment There is no experience with… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 12 words ▾

12.1Mechanism of Action Methylphenidate is a central nervous system (CNS) stimulant.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied QUILLIVANT XR is supplied as powder that, after reconstitution with water, forms an extended-release oral suspension. The product is supplied in a carton. Each carton also contains one bottle, one oral dosing dispenser, and one bottle adapter.

The product must be reconstituted only by the pharmacist and not by the patient or caregiver. After reconstitution, the product is a light beige to tan viscous suspension containing the equivalent of 25 mg of methylphenidate hydrochloride per 5 mL. Bottles of 300 mg (to prepare 60 mL suspension) NDC 24478-321-02 Bottles of 600 mg (to prepare 120 mL suspension) NDC 24478-322-04 Bottles of 750 mg (to prepare 150 mL suspension) NDC 24478-323-05 Bottles of 900 mg (to prepare 180 mL suspension) NDC 24478-324-06

16.2Storage and Handling Store at 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.] Dispense in original container.

16.1How Supplied QUILLIVANT XR is supplied as powder that, after reconstitution with water, forms an extended-release oral suspension. The product is supplied in a carton. Each carton also contains one bottle, one oral dosing dispenser, and one bottle adapter.

The product must be reconstituted only by the pharmacist and not by the patient or caregiver. After reconstitution, the product is a light beige to tan viscous suspension containing the equivalent of 25 mg of methylphenidate hydrochloride per 5 mL. Bottles of 300 mg (to prepare 60 mL suspension) NDC 24478-321-02 Bottles of 600 mg (to prepare 120 mL suspension) NDC 24478-322-04 Bottles of 750 mg (to prepare 150 mL suspension) NDC 24478-323-05 Bottles of 900 mg (to prepare 180 mL suspension) NDC 24478-324-06

📦 Storage and Handling 26 words ▾

16.2Storage and Handling Store at 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.] Dispense in original container.

📋 Description 142 words ▾

11 DESCRIPTION QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate.

Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure C 14 H 19 NO 2 Mol.

Wt. 233.31 QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide. chem draw without HCL

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of QUILLIVANT 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 QUILLIVANT XR in a safe place, preferably locked, and instruct patients to not give QUILLIVANT XR to anyone else.

Instructions for Using the Enclosed Oral Dosing Dispenser Provide the following instructions on administration to the patient or caregiver: The pharmacist should provide this medicine in its original packaging (bottle within carton) with the bottle adapter fully inserted and the accompanying oral dosing dispenser. Use only with the oral dosing dispenser provided with this product. Check and make sure that the QUILLIVANT XR bottle contains liquid medicine.

If QUILLIVANT XR is in powder form, do not use it. Return it to your pharmacist. VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least 10 seconds before each dose, to ensure that the proper dose is administered.

Remove the bottle cap. Confirm that the bottle adapter has been inserted into top of the bottle. Insert the tip of the oral dosing dispenser provided with this product into the bottle adapter.

Turn bottle upside down and withdraw prescribed amount of QUILLIVANT XR into the oral dosing dispenser. Remove filled oral dosing dispenser from bottle and dispense QUILLIVANT XR directly into mouth. Replace bottle cap and store bottle as directed.

Wash oral dosing dispenser after each use (components are dishwasher-safe). Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death with QUILLIVANT XR use. Instruct patients to contact a health care 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 Advise patients that QUILLIVANT XR can elevate blood pressure and heart rate [see Warnings and Precautions (5.3) ]. Psychiatric Adverse Reactions Advise patients that QUILLIVANT XR, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ]. Priapism Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism).

Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5) ]. Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud’s Phenomenon] Instruct patients beginning treatment with QUILLIVANT XR 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 QUILLIVANT XR. 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, families, and caregivers that QUILLIVANT XR can 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 QUILLIVANT XR [see Warnings and Precautions (5.9) ] . Motor and V… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

Medication Guide QUILLIVANT XR ® (\kwil-ə-vant\) (methylphenidate hydrochloride) for extended-release oral suspension CII What is the most important information I should know about QUILLIVANT XR? QUILLIVANT XR may cause serious side effects, including: Abuse, misuse, and addiction. QUILLIVANT XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of QUILLIVANT XR, 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 QUILLIVANT XR 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 QUILLIVANT XR and will monitor you or your child during treatment.

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

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

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

Tell your health care 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 QUILLIVANT XR. Increased blood pressure and heart rate.

Your health care provider should check your or your child’s blood pressure and heart rate regularly during treatment with QUILLIVANT XR. Mental (Psychiatric) problems: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your health care provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your health care provider right away if you or your child have any new or worsening mental symptoms or problems while taking QUILLIVANT XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is QUILLIVANT XR? QUILLIVANT XR is a central nervous system stimulant prescription medicine. QUILLIVANT XR is a liquid medicine that you take by mouth.

It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QUILLIVANT XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. QUILLIVANT XR is not recommended for use in children under 6 years of age with ADHD.

QUILLIVANT XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep QUILLIVANT XR in a safe place to protect it from theft. Never give your QUILLIVANT XR to anyone else, because it may cause death or harm them.

Selling or giving away QUILLIVANT XR may harm others and is against the law. Do not take QUILLIVANT XR if you or your child: are allergic to methylphenidate hydrochloride, or any of the ingredients in QUILLIVANT XR. See the end of this Medication Guide for a complete list of ingredients in QUILLIVANT XR. are taking or have taken within the past 14 days a type of anti-depression medicine called a monoamine oxidase inhibitor (MAOI).

QUILLI… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following a single, 60 mg oral dose of QUILLIVANT XR in 28 healthy adult subjects in a crossover study under fasting conditions, d- methylphenidate ( d- MPH) mean (± SD) peak plasma concentrations of 13.6 (± 5.8) ng/mL occurred at a median time of 5 hours after dosing (Figure 2). The relative bioavailability of QUILLIVANT XR compared to Methylphenidate IR oral solution (2x30 mg, q6h) is 95%. Figure 2: Mean d- Methylphenidate Plasma Concentration-Time Profiles The single dose pharmacokinetics of d- MPH under fed conditions are summarized (Table 3) from studies in children and adolescents with ADHD, and healthy adults following an oral dose of 60 mg QUILLIVANT XR.

Table 3: d-MPH PK Parameters (mean ±SD) after 60 mg oral dosing of QUILLIVANT XR* PK Parameter Children† (n=3) Adolescent† (n=4) Adult (n=27) T max (hr) ‡ 4.05 (3.98-6.0) 2.0 (1.98-4.0) 4.0 (1.3-7.3) T 1/2 (hr) 5.2±0.1 5.0±0.2 5.2±1.0 C max (ng/mL) 34.4±14.0 21.1±5.9 17.0±7.7 AUC inf (hr*ng/mL) 378±175 178±54.2 163.2±80.3 Cl (L/hr/kg) 4.27±0.70 5.06±1.42 5.66±2.15 * Breakfast was given 30 min prior to drug administration † total MPH measured in children (9 to 12 years old) and adolescents (13 to 15 years old), l- MPH <2% of d- MPH in circulation ‡ data presented as median (range) Food Effects In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of QUILLIVANT XR at a dose of 60 mg, the presence of food reduced the time to peak concentration by approximately 1 hour (fed: 4 hours vs. fasted: 5 hours).

Overall, a high-fat meal increased the average C max of QUILLIVANT XR by about 28% and the AUC by about 19%. These changes are not considered clinically significant. Elimination Following a single 60 mg oral dose of QUILLIVANT XR in 28 healthy adult subjects under fasting conditions, the mean plasma terminal elimination half-life of d- methylphenidate was 5.6 (± 0.8) hours.

Metabolism In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenyl-piperidine acetic acid (PPAA). The metabolite has little or no pharmacologic activity. Excretion After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine.

The main urinary metabolite was PPAA, accounting for approximately 80% of the dose. Alcohol Effect An in vitro study was conducted to explore the effect of alcohol on the release characteristics of methylphenidate from QUILLIVANT XR Oral Suspension. At alcohol concentrations of 5% and 10%, there was no effect of alcohol on the release characteristics of methylphenidate.

At 20% alcohol concentration, there was on average a 20% increase in drug exposure [see Dosage and Administration ( 2.2 ) ]. Specific Populations Sex There is insufficient experience with the use of QUILLIVANT XR to detect gender variations in pharmacokinetics. Race There is insufficient experience with the use of QUILLIVANT XR to detect ethnic variations in pharmacokinetics.

Age The pharmacokinetics of methylphenidate after QUILLIVANT XR administration were studied in pediatric patients with ADHD between 9 and 15 years of age. After a single oral dose of 60 mg QUILLIVANT XR, plasma concentrations of methylphenidate in children (9 to 12 years old; n=3) were approximately twice the concentrations observed in adults. The plasma concentrations in adolescent patients (13 to 15 years old; n=4) were similar to those in adults.

Renal Impairment There is no experience with the use of QUILLIVANT XR in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of PPAA. Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of QUILLIVANT XR.

Hepatic Impairment There is no experience with the use of… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 59 words ▾

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l- isomers. The d- isomer is more pharmacologically active than the l ‑ isomer. The mode of therapeutic action in ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of QUILLIVANT XR was evaluated in a laboratory classroom study conducted in 45 pediatric patients (ages 6 to 12 years) with ADHD. Patients in the trial met Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV ® ) criteria for ADHD. The study began with an open-label dose optimization period (4 to 6 weeks) with an initial QUILLIVANT XR dose of 20 mg once daily in the morning.

The dose could be titrated weekly in increments of 10 or 20 mg until a therapeutic dose or the maximum dose of 60 mg/day was reached. At the end of the dose optimization period, approximately 5% of subjects were receiving 20 mg/day; 39%, 30 mg/day; 31%, 40 mg/day; 10%, 50 mg/day; and 15%, 60 mg/day. Subjects then entered a 2-week randomized, double-blind, crossover treatment with the individually optimized dose of QUILLIVANT XR or placebo.

At the end of each week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy endpoints were the SKAMP-Combined scores at 0.75, 2, 8, 10, and 12 hours post-dosing.

Results from the first double-blind, placebo-controlled week of the study are summarized in Figure 3. SKAMP-Combined scores were statistically significantly lower (improved) at all time points (0.75, 2, 4, 8, 10, 12 hours) post-dosing with QUILLIVANT XR compared to placebo. Figure 3: Absolute SKAMP-Combined Score after treatment with QUILLIVANT XR or Placebo during Period 1.

Figure 3

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance QUILLIVANT XR contains methylphenidate, a Schedule II controlled substance.

9.2Abuse QUILLIVANT XR has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . QUILLIVANT XR can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect.

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

Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including QUILLIVANT XR, 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.

9.3Dependence Physical Dependence QUILLIVANT XR may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including QUILLIVANT XR include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

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

🔒 Controlled Substance 12 words ▾

9.1Controlled Substance QUILLIVANT XR contains methylphenidate, a Schedule II controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 4 times the maximum recommended human dose on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type.

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 5 times the maximum recommended human dose on a mg/m 2 basis.

Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in an in vivo mouse bone marrow micronucleus assay.

Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 8-fold the maximum recommended human dose on a mg/m 2 basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 4 times the maximum recommended human dose on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type.

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 5 times the maximum recommended human dose on a mg/m 2 basis.

Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in an in vivo mouse bone marrow micronucleus assay.

Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 8-fold the maximum recommended human dose on a mg/m 2 basis.

📄 Patient Package Insert ~2 min read ▾

Instructions for Use QUILLIVANT XR® (\kwil-ə-vant\) (methylphenidate hydrochloride) for extended-release oral suspension CII Read this Instructions for Use before using QUILLIVANT XR and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the health care provider about your or your child’s medical condition or treatment.

Step 1. Remove the QUILLIVANT XR bottle and oral dosing dispenser from the box (See Figure A). If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.

Step 2. Check and make sure that the QUILLIVANT XR bottle contains liquid medicine (See Figure B). If QUILLIVANT XR is still in powder form, do not use it.

Return it to your pharmacist. Step 3. Shake the bottle well (up and down) for at least 10 seconds before each use (See Figure C).

Step 4. Uncap the bottle and check that the bottle adapter has been fully inserted into the bottle (See Figure D). Step 4 (continued).

If bottle adapter (See Figure E) has not been inserted by the pharmacist into the bottle, insert adapter into the bottle as shown (See Figure E and Figure F). After the bottle adapter has been fully inserted into the bottle (See Figure G) , it should not be removed. If the bottle adapter has not been inserted and is missing from the box, contact your pharmacist.

The bottle adapter must be fully inserted and should be even with the mouth of the bottle and must remain in place to allow the child resistant cap to work the right way. Step 5. Check the QUILLIVANT XR dose in milliliters (mL) as prescribed by your health care provider.

Locate this number on the oral dosing dispenser (See Figure H). Step 6. Insert tip of the oral dosing dispenser into the upright bottle and push the plunger all the way down (See Figure I).

Step 7. With the oral dosing dispenser in place, turn the bottle upside down. Pull the plunger to the number of mL you need (the amount of liquid medicine in Step 5 – See Figure J ).

Step 7 (continued). Measure the number of mL of medicine from the white end of the plunger (See Figure K). Step 8.

Remove the oral dosing dispenser from the bottle adapter. Step 9. Slowly squirt QUILLIVANT XR directly into your or your child’s mouth (See Figure L).

Step 10. Cap the bottle tightly. Store the bottle upright at 59°F to 86°F (15°C to 30°C) (See Figure M).

Figure M Step 11. Clean the oral dosing dispenser after each use by placing in the dishwasher, or by rinsing with tap water (See Figure N). Figure N These Instructions for Use have been approved by the U.S.

Food and Drug Administration. Revised: 06/2021 This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com .

Distributed by: Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852 LB8529 Rev. 01 06/2021 FigureA FigureB FigureC FigureD FigureE_F FigureG FigureH FigureI FigureJ FigureK FigureL FigureM FigureN Next wave 30%

📄 Recent Major Changes 22 words ▾

Dosage Forms and Strengths ( 3 ) 03/2026 Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.7 ) 09/2025

📄 Package Label / Principal Display Panel 148 words ▾

PRINCIPAL DISPLAY PANEL NDC 24478-321-02 QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension 300 mg/ 60 mL total volume (When reconstituted with 53 mL of water) 25 mg/5 mL (5 mg/mL) When reconstituted Rx Only 300mg carton

PRINCIPAL DISPLAY PANEL NDC 24478-322-04 QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension 600 mg/ 120 mL total volume (When reconstituted with 105 mL of water) 25 mg/5 mL (5 mg/mL) When reconstituted Rx Only 600mg carton

PRINCIPAL DISPLAY PANEL NDC 24478-323-05 QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension 750 mg/ 150 mL total volume (When reconstituted with 131 mL of water) 25 mg/5 mL (5 mg/mL) When reconstituted Rx Only 750mg carton

PRINCIPAL DISPLAY PANEL NDC 24478-324-06 QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension 900 mg/ 180 mL total volume (When reconstituted with 158 mL of water) 25 mg/5 mL (5 mg/mL) When reconstituted Rx Only 900mg carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
82.2K
Units reimbursed last 4 qtrs
13.1M
Gross reimbursed last 4 qtrs
$35.77M
Avg / prescription
$435.36
Avg / unit
$2.7306
Latest quarter Q1 2026
20.9KRx
Medicaid pays / mL
$2.7306
gross reimbursed
vs
NADAC / mL
$2.7009
acquisition cost
=
Spread
+$0.0297
+1% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
29% FFS 71% MCO
Fee-for-service · 24,184 Rx Managed care · 57,981 Rx
State Medicaid map
Alaska: 15,000 units · 2,046 per 100k residents AK Maine: 62,340 units · 4,469 per 100k residents ME Washington: 46,230 units · 592 per 100k residents WA Idaho: 91,515 units · 4,660 per 100k residents ID Montana: 2,760 units · 244 per 100k residents MT North Dakota: 6,720 units · 858 per 100k residents ND Minnesota: 29,100 units · 507 per 100k residents MN Wisconsin: 200,175 units · 3,387 per 100k residents WI Michigan: 328,812 units · 3,276 per 100k residents MI New York: 209,806 units · 1,072 per 100k residents NY Vermont: 41,640 units · 6,436 per 100k residents VT New Hampshire: 25,080 units · 1,789 per 100k residents NH Oregon: 25,920 units · 612 per 100k residents OR Nevada: no data reported NV Wyoming: 1,680 units · 288 per 100k residents WY South Dakota: 43,710 units · 4,756 per 100k residents SD Iowa: 68,475 units · 2,135 per 100k residents IA Illinois: 18,420 units · 147 per 100k residents IL Indiana: 708,540 units · 10,326 per 100k residents IN Ohio: 336,720 units · 2,857 per 100k residents OH Pennsylvania: 642,544 units · 4,958 per 100k residents PA New Jersey: 17,310 units · 186 per 100k residents NJ Massachusetts: 75,240 units · 1,075 per 100k residents MA California: 299,067 units · 768 per 100k residents CA Utah: 113,640 units · 3,326 per 100k residents UT Colorado: 25,800 units · 439 per 100k residents CO Nebraska: 63,330 units · 3,202 per 100k residents NE Missouri: 631,080 units · 10,185 per 100k residents MO Kentucky: 102,120 units · 2,256 per 100k residents KY West Virginia: 198,480 units · 11,214 per 100k residents WV Virginia: 118,780 units · 1,363 per 100k residents VA Maryland: 503,325 units · 8,144 per 100k residents MD Connecticut: 328,820 units · 9,091 per 100k residents CT Rhode Island: 15,510 units · 1,416 per 100k residents RI Arizona: 23,640 units · 318 per 100k residents AZ New Mexico: no data reported NM Kansas: 211,800 units · 7,204 per 100k residents KS Arkansas: no data reported AR Tennessee: 208,000 units · 2,919 per 100k residents TN North Carolina: 2,755,074 units · 25,428 per 100k residents NC South Carolina: 243,240 units · 4,527 per 100k residents SC Delaware: 56,040 units · 5,435 per 100k residents DE Oklahoma: 32,400 units · 799 per 100k residents OK Louisiana: 468,375 units · 10,240 per 100k residents LA Mississippi: 407,970 units · 13,877 per 100k residents MS Alabama: 136,980 units · 2,682 per 100k residents AL Georgia: 82,320 units · 746 per 100k residents GA D.C.: 1,560 units · 230 per 100k residents DC Hawaii: no data reported HI Texas: 2,767,590 units · 9,073 per 100k residents TX Florida: 254,370 units · 1,125 per 100k residents FL
Units reimbursed · per 100k residents
14725,428
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 North Carolina 25,428 /100k
2 Mississippi 13,877 /100k
3 West Virginia 11,214 /100k
4 Indiana 10,326 /100k
5 Louisiana 10,240 /100k
6 Missouri 10,185 /100k
7 Connecticut 9,091 /100k
8 Texas 9,073 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Quillivant XR — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Quillivant XR. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.7K
Claims incl. refills
101
Beneficiaries
53
Spend / beneficiary
$1,012.71
Spend / claim
$531.42
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
NextWave 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.
← 24478-0321-02 · NextWave 24478-0323-05 · NextWave →
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.