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QuilliChew ER methylphenidate hydrochloride 30 mg Tablet, Chewable, Extended Release, 30-count — NDC 24478-0075-02 package photo

QuilliChew ER methylphenidate hydrochloride 30 mg Tablet, Chewable, Extended Release, 30-count

by NextWave Pharmaceuticals, Inc · 30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-02)
NDC 24478-0075-02
🏷️ FDA NDC (as labeled) 24478-075-02 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 100 tablets 24478-0075-01
Rx only Brand On market CII
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

🆔 Identity & classification

FDA NDC (as labeled) 24478-075-02
Product NDC 24478-075
11-digit billing NDC 24478007502
Application # NDA207960
SPL Set ID defc1205-8e90-4b1e-b862-05e4c35c7364
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-18
Route ORAL
Dosage form TABLET, CHEWABLE, EXTENDED RELEASE
Substance METHYLPHENIDATE HYDROCHLORIDE
GCN Seq No 075264
GCN 40292
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 QUILLICHEW ER 30 MG CHEW TAB
FDB brand name Quillichew Er
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 24478-075-02 — 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 → 24478-0075-02. 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.

🏭 Manufacturer & labeler

LabelerNextWave Pharmaceuticals, Inc
Application holderNEXTWAVE PHARMACEUTICALS INC
FDA applicationNDA207960 (NDA)
Labeler code24478
First marketedApr 2016
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio13 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name QUILLICHEW ER 30 MG CHEW TAB Ingredient Methylphenidate Hcl
📗 Our plain-language guide HelloPharmacist
  • Methylphenidate helps boost two brain chemicals — dopamine and norepinephrine — that play a big role in attention, focus, and impulse control. When those chemicals are more availab...
  • What exactly is methylphenidate supposed to do for my ADHD?
  • Methylphenidate is a controlled substance, and it does have a real potential for abuse and dependence — that's something the FDA takes seriously enough to put a boxed warning on th...
  • The most common ones — decreased appetite, some trouble sleeping, headache, and a slightly faster heartbeat — are annoying but usually manageable and tend to improve over time. For...
📖 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.

💊 What it looks like

Color white / pink
ShapeOval
ImprintNP;14
Size3 mm
ScoringNot scored
FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII BUC5I9595W
    A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 2S42T2808B
    A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
  • UNII E89I1637KE
    Guar gum is a natural thickener made from guar bean seeds. It's used in medicines as a binder and thickening agent to hold ingredients together and create the right texture and consistency.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 32K497ZK2U
    Polyvinyl acetate is a synthetic plastic polymer derived from vinyl acetate. It acts as a binder and film-forming agent in medicines, helping to hold ingredients together and create protective coatings on tablets or capsules.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 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 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
QuilliChew ER 30 mgthis 24478-0075-02 NextWave 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
First FDA approval
Dec 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 4, 2015 RLD RS ⏳ ~6.9 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 9545399 — method of use (U-1827)
US 9295642 — method of use (U-1827)
US 9844544 — method of use (U-2203)
US 9545399 — method of use (U-1827)
US 11103495 — method of use (U-2993)
US 11103495 — method of use (U-2993)
US 9545399 — method of use (U-1827)
US 9295642 — method of use (U-1827)
US 9844544 — method of use (U-2203)
US 9844544 — method of use (U-2203)
US 10857143 — method of use (U-2993)
US 10857143 — method of use (U-2993)
US 10857143 — method of use (U-2993)
US 11103495 — method of use (U-2993)
US 9295642 — method of use (U-1827)
US 11103494 — drug product
US 8999386 — drug product
US 11633389 — drug product
US 11633389 — drug product
US 8202537 — drug product
US 11103494 — drug product
US 8202537 — drug product
US 11103494 — drug product
US 8999386 — drug product
US 8999386 — drug product
US 8287903 — drug product
US 8287903 — drug product
US 8287903 — drug product
US 8202537 — drug product
US 11633389 — drug product
2015 2017 2019 2021 2023 2025 2027 2029 2031 2033
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 (30)
PatentTypeUse codeExpires
US 9545399 ↗ Method of use U-1827 Aug 14, 2033
US 9295642 ↗ Method of use U-1827 Aug 14, 2033
US 9844544 ↗ Method of use U-2203 Aug 14, 2033
US 9545399 ↗ Method of use U-1827 Aug 14, 2033
US 11103495 ↗ Method of use U-2993 Aug 14, 2033
US 11103495 ↗ Method of use U-2993 Aug 14, 2033
US 9545399 ↗ Method of use U-1827 Aug 14, 2033
US 9295642 ↗ Method of use U-1827 Aug 14, 2033
US 9844544 ↗ Method of use U-2203 Aug 14, 2033
US 9844544 ↗ Method of use U-2203 Aug 14, 2033
US 10857143 ↗ Method of use U-2993 Aug 14, 2033
US 10857143 ↗ Method of use U-2993 Aug 14, 2033
US 10857143 ↗ Method of use U-2993 Aug 14, 2033
US 11103495 ↗ Method of use U-2993 Aug 14, 2033
US 9295642 ↗ Method of use U-1827 Aug 14, 2033
US 11103494 ↗ Drug product — Aug 14, 2033
US 8999386 ↗ Drug product — Aug 14, 2033
US 11633389 ↗ Drug product — Aug 14, 2033
US 11633389 ↗ Drug product — Aug 14, 2033
US 8202537 ↗ Drug product — Mar 15, 2027
US 11103494 ↗ Drug product — Aug 14, 2033
US 8202537 ↗ Drug product — Mar 15, 2027
US 11103494 ↗ Drug product — Aug 14, 2033
US 8999386 ↗ Drug product — Aug 14, 2033
US 8999386 ↗ Drug product — Aug 14, 2033
US 8287903 ↗ Drug product — Feb 15, 2031
US 8287903 ↗ Drug product — Feb 15, 2031
US 8287903 ↗ Drug product — Feb 15, 2031
US 8202537 ↗ Drug product — Mar 15, 2027
US 11633389 ↗ Drug product — Aug 14, 2033
Common questions
Is there a generic version of QUILLICHEW ER 30 MG CHEW TAB?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for QUILLICHEW ER 30 MG CHEW TAB. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2033 — an estimate, not a guaranteed launch date.
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets24478-0075-01 70,624 Rx · $27,450,650
30 tablets this page24478-0075-02 No Medicaid data
Drug total (last 4 qtrs): 70,624 Rx · 2,266,413 units · $27,450,650 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Quillichew ER — 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 Quillichew ER. 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
$70.4K
Claims incl. refills
165
Beneficiaries
77
Spend / beneficiary
$914.93
Spend / claim
$426.97
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
24478-0075-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-01) $11.88 / ea $1,188.44 2016-04-18 Active
24478-0075-02 You're viewing this 30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-02) — — 2026-09-14 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 24478-0075-02?
NDC 24478-0075-02 is a 30-count package — 30 tablet, chewable, extended release in 1 bottle.
What is the difference between NDC 24478-0075-02 and NDC 24478-0075-01?
Both are QuilliChew ER methylphenidate hydrochloride 30 mg Tablet, Chewable, Extended Release — the drug itself is identical. NDC 24478-0075-02 is the 30-count package, while NDC 24478-0075-01 is the 100 tablets package.
What NDC number is used to bill for this package of QuilliChew ER methylphenidate hydrochloride 30 mg Tablet, Chewable, Extended Release?
Bill NDC 24478-0075-02 — the 11-digit billing format is 24478007502. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 24478-075-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 24478-0075-02, written without dashes as 24478007502. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 24478-0075-02, the first segment (24478) is the labeler code FDA assigned to NextWave Pharmaceuticals, Inc; the middle segment (0075) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NextWave Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (24478-0075-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE AND ADDICTION QuilliChew ER 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 QuilliChew ER, 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 QuilliChew ER, 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 QuilliChew ER treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.

QUILLICHEW ER 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 QUILLICHEW ER, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing QUILLICHEW ER, 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 159 words ▾

1 INDICATIONS AND USAGE QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. Limitations of Use The use of QuilliChew ER 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 ) ]. QuilliChew ER is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

( 1 ) Limitations of Use The use of QuilliChew ER 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 ~2 min read ▾

2 DOSAGE AND ADMINISTRATION QuilliChew ER may be taken with or without food. ( 2.1 ) For patients 6 years and above, recommended starting dose is 20 mg given orally once daily in the morning. Dosage may be titrated weekly in increments of 10 mg, 15 mg or 20 mg per day. Daily dosage above 60 mg is not recommended. ( 2.1 )

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

2.2Recommended Dosage The recommended starting dosage of QuilliChew ER for patients 6 years and above is 20 mg once daily orally in the morning. The dose may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively.

Daily doses above 60 mg have not been studied and are not recommended. As with any CNS stimulant, during titration of QuilliChew ER, the prescribed dose should be adjusted, if necessary, until a well-tolerated, therapeutic dose is achieved.

2.3Administration Instructions QuilliChew ER 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 QuilliChew ER 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 ) ].

2.5Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reaction occur, reduce dosage, or, if necessary, discontinue QuilliChew ER. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue QuilliChew ER.

💊 Dosage Forms and Strengths 131 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release chewable tablets contain the equivalent of: 20 mg methylphenidate HCl available as a speckled, off-white, capsule-shaped coated tablet, debossed with "NP 12" on one side and functionally scored on the other side. 30 mg methylphenidate HCl available as a speckled, light pink color, capsule-shaped coated tablet, debossed with "NP 13" on one side and functionally scored on the other side. 40 mg methylphenidate HCl available as a speckled, dark pink to peach color, capsule-shaped coated tablet, debossed with "NP 14" on one side and plain (not scored) on the other side.

Extended-release chewable tablets: equivalent of 20 mg and 30 mg of methylphenidate hydrochloride (HCl), functionally scored ( 3 ) Extended-release chewable tablets: equivalent of 40 mg of methylphenidate HCl, not scored ( 3 )

⛔ Contraindications 134 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 QuilliChew ER QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of QuilliChew ER. 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 QuilliChew ER is contraindicated during concomitant 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 QuilliChew ER, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing QuilliChew ER. ( 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 QuilliChew ER 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 ) Risks in Phenylketonurics: QuilliChew ER extended-release chewable tablets contain phenylalanine, a component of aspartame. ( 5.8 ) Acute Angle Closure Glaucoma: QuilliChew ER -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. ( 5.9 ) Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe QuilliChew ER 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. ( 5.10 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating QuilliChew ER, 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. ( 5.11 )

5.1Abuse, Misuse, and Addiction QuilliChew ER has a high potential for abuse and misuse. The use of QuilliChew ER exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. QuilliChew ER 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 QuilliChew ER, 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 QuilliChew ER, 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 QuilliChew ER in a safe place, preferably locked, and instruct patients to not give QuilliChew ER to anyone else. Throughout QuilliChew ER 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 QuilliChew ER 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 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases. Monitor all QuilliChew…

🤒 Adverse Reactions ~3 min read ▾

6 A DVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Known hypersensitivity to methylphenidate products or other ingredients of QuilliChew ER [see Contraindications (4.1) ] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4.2) , 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) ] • Risks in Phenylketonuria [see Warnings and Precautions (5.8) ] • Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9) ] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10) ] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.11) ] 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 QuilliChew ER in Children with ADHD There is limited experience with QuilliChew ER in controlled trials. The safety data in this section is based on data from a laboratory classroom study conducted in 90 pediatric subjects (ages 6 to 12 years) with ADHD. The study consisted of a 6-week dose optimization period, followed by a randomized, double-blind, parallel group treatment period with the individually optimized dose of QuilliChew ER or placebo.

The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the double-blind, randomized, placebo-controlled phase in patients optimized to doses of QuilliChew ER 20 to 60 mg/day are described in Table 1. Table 1: Common Adverse Reactions Occurring in ≥2% of Subjects on QuilliChew ER and Greater than Placebo During the Double-Blind Period of the ADHD Laboratory Classroom Study Adverse reaction QuilliChew ER N= 4 2 n (%) Placebo N= 4 4 n (%) Decreased appetite 1 (2.4) 0 (0) Aggression 1 (2.4) 0 (0) Emotional poverty 1 (2.4) 0 (0) Nausea 1 (2.4) 0 (0) Headache 1 (2.4) 0 (0) Weight decreased 1 (2.4) 0 (0)

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntaril…

🔄 Drug Interactions 182 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 QuilliChew ER 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 QuilliChew ER 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 QuilliChew ER may increase the risk of sudden blood pressure and heart rate increase during surgery.

Avoid use of QuilliChew ER 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 QuilliChew ER, 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 QuilliChew ER and any potential adverse effects on the breastfed infant from QuilliChew ER 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 QuilliChew ER 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 QuilliChew ER have been established in pediatric patients ages 6 to 17 years. Use of QuilliChew ER in these age groups is based on one adequate and well-contro…

🤰 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 QuilliChew ER, 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 QuilliChew ER 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 QuilliChew ER have been established in pediatric patients ages 6 to 17 years. Use of QuilliChew ER in these age groups is based on one adequate and well-controlled clinical study in pediatric patients 6 to 12 years old, pharmacokinetic data in adolescents and adults, and safety information from other methylphenidate-containing products. Long Term Suppression of Growth Growth should be monitored during treatment with CNS stimulants, including QuilliChew ER.

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 QuilliChew ER 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 QuilliChew ER 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 ~2 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 oral dose of 40 mg QuilliChew ER under fasting conditions, plasma methylphenidate reached maximal concentration (C max ) at a median time of 5 hours after dosing. Compared to an immediate-release formulation of methylphenidate chewable tablet (40 mg in 2 equal doses of 20 mg, 6 hours apart), methylphenidate mean peak concentration and exposure (AUC inf ) was about 20% and 11% lower, respectively, after single dose administration of 40 mg QuilliChew ER (Figure 2). Figure 2: Mean Methylphenidate Plasma Concentration-Time Profiles After Administration of 40 mg QuilliChew ER or Methylphenidate Immediate-Release Chewable Tablets (IRCT, 2 Equal Doses of 20 mg, 6 Hours Apart) Under Fasted Conditions in Healthy Volunteers Food Effect High-fat meal had no effect on the time to peak concentration, and increased C max and systemic exposure (AUC inf ) of methylphenidate by about 20% and 4%, respectively, after a single dose administration of 40 mg QuilliChew ER.

Elimination Plasma methylphenidate concentrations decline monophasically following oral administration of QuilliChew ER. The mean plasma terminal elimination half-life of methylphenidate was about 5.2 hours in healthy volunteers following a single 40 mg dose administration. Metabolism In humans, methylphenidate is metabolized primarily via de-esterification 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 At 40% alcohol concentration, there was about 90% release methylphenidate from QuilliChew ER 40 mg tablet within half an hour. The results with the 40 mg chewable tablet strength are considered representative of the other available tablet strengths. Specific Populations Sex There is insufficient experience with the use of QuilliChew ER to detect gender variations in pharmacokinetics.

Race There is insufficient experience with the use of QuilliChew ER to detect ethnic variations in pharmacokinetics. Age There are no specific pediatric pharmacokinetic studies for QuilliChew ER. However, the pharmacokinetics of methylphenidate in pediatric patients 6 to 17 years old are not expected to be significantly different from adults following QuilliChew ER administration.

Renal Impairment There is no experience with the use of QuilliChew ER 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 QuilliChew ER.

Hepatic Impairment There is no experience with the use of QuilliChew ER in patients with hepatic insufficiency. Figure2

🧬 Mechanism of Action 12 words ▾

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

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied QuilliChew ER is supplied as extended-release chewable tablets in 20 mg, 30 mg and 40 mg strengths. The 20 mg strength extended-release chewable tablet is available as a speckled, off-white, capsule-shaped coated tablet, debossed with "NP 12" on one side and functionally scored on the other side. The 30 mg strength extended-release chewable tablet is available as a speckled, light pink color, capsule-shaped coated tablet, debossed with "NP 13" on one side and functionally scored on the other side.

The 40 mg strength extended-release chewable tablet is available as a speckled, dark pink to peach color, capsule-shaped coated tablet, debossed with "NP 14" on one side and plain on the other side (not scored). The product is supplied in bottles of 30 and 100. Package Configuration Tablet Strength (mg) NDC Print Bottles of 30 20 mg NDC 24478‑074‑02 NP 12 Bottles of 100 20 mg NDC-24478-074-01 NP 12 Bottles of 30 30 mg NDC 24478‑075‑02 NP 13 Bottles of 100 30 mg NDC-24478-075-01 NP 13 Bottles of 30 40 mg NDC 24478‑076‑02 NP 14 Bottles of 100 40 mg NDC-24478-076-01 NP 14 QuilliChew ER extended-release chewable tablets

16.2Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]

16.1How Supplied QuilliChew ER is supplied as extended-release chewable tablets in 20 mg, 30 mg and 40 mg strengths. The 20 mg strength extended-release chewable tablet is available as a speckled, off-white, capsule-shaped coated tablet, debossed with "NP 12" on one side and functionally scored on the other side. The 30 mg strength extended-release chewable tablet is available as a speckled, light pink color, capsule-shaped coated tablet, debossed with "NP 13" on one side and functionally scored on the other side.

The 40 mg strength extended-release chewable tablet is available as a speckled, dark pink to peach color, capsule-shaped coated tablet, debossed with "NP 14" on one side and plain on the other side (not scored). The product is supplied in bottles of 30 and 100. Package Configuration Tablet Strength (mg) NDC Print Bottles of 30 20 mg NDC 24478‑074‑02 NP 12 Bottles of 100 20 mg NDC-24478-074-01 NP 12 Bottles of 30 30 mg NDC 24478‑075‑02 NP 13 Bottles of 100 30 mg NDC-24478-075-01 NP 13 Bottles of 30 40 mg NDC 24478‑076‑02 NP 14 Bottles of 100 40 mg NDC-24478-076-01 NP 14 QuilliChew ER extended-release chewable tablets

📦 Storage and Handling 26 words ▾

16.2Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]

📋 Description ~1 min read ▾

11 DESCRIPTION QuilliChew ER (methylphenidate hydrochloride extended-release chewable tablets) contains methylphenidate and methylphenidate hydrochloride. QuilliChew ER is available in three dosage strengths - 20 mg, 30 mg and 40 mg. The dosage strengths are expressed in terms of methylphenidate hydrochloride equivalents; however only 15% of methylphenidate is present as methylphenidate hydrochloride salt.

The remaining 85% is present as methylphenidate complexed with sodium polystyrene sulfonate. QuilliChew ER contains the equivalent of approximately 30% immediate-release and 70% extended-release methylphenidate. Dosage Strength Dosage strength in terms of equivalent amount of methylphenidate HCl Dosage strength in terms of equivalent amount of methylphenidate Actual methylphenidate HCl content Actual Methylphenidate content 20 mg 20 mg 17.30 mg 3.00 mg 14.70 mg 30 mg 30 mg 25.95 mg 4.50 mg 22.05 mg 40 mg 40 mg 34.59 mg 6.00 mg 29.40 mg The QuilliChew ER extended-release chewable tablets are cherry flavored.

Methylphenidate is a central nervous system (CNS) stimulant. The chemical name is methyl α- phenyl-2-piperidineacetate. Figure 1: Methylphenidate C 14 H 19 NO 2 Mol.

Wt. 233.31 QuilliChew ER also contains the following inactive ingredients: aspartame [see Warnings and Precautions ( 5.8 ) ] , cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum. figure1

💬 Information for Patients ~3 min read ▾

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

Dosage and Administration Instructions Advise patients that QuilliChew ER should be taken by mouth once daily in the morning with or without food. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with QuilliChew ER 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 QuilliChew ER can elevate blood pressure and heart rate [see Warnings and Precautions (5.3) ]. Psychiatric Adverse Reactions Advise patients that QuilliChew ER, 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 QuilliChew ER 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 QuilliChew ER. 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 QuilliChew ER can cause slowing of growth and weight loss [see Warnings and Precautions (5.7) ].

Alcohol Effect Advise patients to avoid alcohol while taking QuilliChew ER extended-release chewable tablets. Consumption of alcohol while taking QuilliChew ER may result in a more rapid release of the dose of methylphenidate [see Clinical Pharmacology (12.3) ]. Risks in Patients with Phenylketonuria (PKU) Advise patients with phenylketonuria that QuilliChew ER extended-release chewable tablets contain phenylalanine, a component of aspartame [see Warnings and Precautions (5.8) ].

Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with QuilliChew ER [see Warnings and Precautions (5.9) ]. Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with QuilliChew ER. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10) ].

Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to QuilliChew ER during pregnancy [see Use in Specific Populations (8.1) ]. Lactation Advise nursing mother to m…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE QuilliChew ER ® (quil-ih' CHOO' ee-ahr) (methylphenidate hydrochloride) extended-release chewable tablets CII What is the most important information I should know about QuilliChew ER? QuilliChew ER may cause serious side effects, including: Abuse, misuse, and addiction. QuilliChew ER has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of QuilliChew ER, 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 QuilliChew ER 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 QuilliChew ER and will monitor you or your child during treatment.

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

Keep QuilliChew ER in a safe place and properly dispose of any unused medicine. See “ How should I store QuilliChew ER ?” 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 QuilliChew ER.

Tell your healthcare provider if you or your child have any 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 QuilliChew ER. 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 QuilliChew ER. 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 healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking QuilliChew ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is QuilliChew ER? QuilliChew ER is a central nervous system stimulant prescription medicine. QuilliChew ER is an extended-release chewable tablet.

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

QuilliChew ER 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 QuilliChew ER in a safe place to protect it from theft. Never give your QuilliChew ER to anyone else, because it may cause death or harm them.

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

QuilliChew ER may not be right for you o…

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