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Cotempla XR-ODT Methylphenidate 8.6 mg Tablet, Orally Disintegrating — NDC 70165-0100-30 package photo

Cotempla XR-ODT Methylphenidate 8.6 mg Tablet, Orally Disintegrating

by Neos Therapeutics Brands, LLC · 5 BLISTER PACK in 1 CARTON (70165-100-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
NDC 70165-0100-30
🏷️ FDA NDC (as labeled) 70165-100-30 billing pads the product segment with a zero
Rx only Brand On market CII
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Methylphenidate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 10, 2023 — Defective Delivery System: Out of specification for shear. (Noven Pharmaceuticals Inc) · FDA recall D-0473-2023
Class II · Mar 10, 2023 — Defective Delivery System: Out of specification for shear. (Noven Pharmaceuticals Inc) · FDA recall D-0470-2023
Class II · Mar 10, 2023 — Defective Delivery System: Out of specification for shear. (Noven Pharmaceuticals Inc) · FDA recall D-0471-2023
Class II · Mar 10, 2023 — Defective Delivery System: Out of specification for shear. (Noven Pharmaceuticals Inc) · FDA recall D-0472-2023
Class II · Nov 16, 2022 — Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches. (Noven Pharmaceuticals Inc) · FDA recall D-0071-2023
Class II · Jun 24, 2022 — Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer. (Noven Pharmaceuticals Inc) · FDA recall D-1169-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70165-100-30
Product NDC 70165-100
11-digit billing NDC 70165010030
NCPDP billing unit EA — each (per item)
RxCUI 1926840, 1926847, 1926849, 1926851, 1926853, 1926855
UNII 207ZZ9QZ49
Application # NDA205489
SPL Set ID 33f70f58-c871-42c8-8adb-345caeafefcd
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 2017-06-20
Route ORAL
Dosage form TABLET, ORALLY DISINTEGRATING
Substance METHYLPHENIDATE
GPI-14 6140002000H410
GPI class Cotempla XR-ODT
GCN Seq No 077494
GCN 43534
HICL code 033556
Ingredient (HICL) Methylphenidate
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 COTEMPLA XR-ODT 8.6 MG TABLET
FDB brand name Cotempla Xr-Odt
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70165-100-30 — 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 → 70165-0100-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

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

🏭 Manufacturer & labeler

LabelerNeos Therapeutics Brands, LLC
Application holderNEOS THERAPEUTICS INC
FDA applicationNDA205489 (NDA)
Labeler code70165
First marketedJun 2017
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio9 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 COTEMPLA XR-ODT 8.6 MG TABLET Ingredient Methylphenidate
📖 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
  • 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 purple
ShapeRound
ImprintT3
Size12 mm
ScoringNot scored
FlavorGrape
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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • 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 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 70KO0R01RY
    A synthetic resin made from polystyrene with sulfonic acid groups attached. It acts as a binder and helps control how the medication is released in the body by absorbing water and forming a gel-like matrix.
  • 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 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 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $18.075 $542.26 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $17.14 $514.29 / 30 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Apr 2023 Jan 2026 Aug 2026 $18.075 $14.196
▲ Up 26% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cotempla XR-ODT 8.6 mgthis 70165-0100-30 Neos 6 tablets $18.075 AB Availability likely —
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

🏛️
2017
First FDA approval
Jun 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2038
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 Jan 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 19, 2017 AB TE-rated RLD RS ⏳ ~11.4 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 11166947 — method of use (U-3299)
US 11166947 — method of use (U-3299)
US 11166947 — method of use (U-3299)
US 9072680 — drug product
US 9089496 — drug product
US 9089496 — drug product
US 9089496 — drug product
US 8840924 — drug product
US 9072680 — drug product
US 9072680 — drug product
US 8840924 — drug product
US 8840924 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037
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 (12)
PatentTypeUse codeExpires
US 11166947 ↗ Method of use U-3299 Jan 25, 2038
US 11166947 ↗ Method of use U-3299 Jan 25, 2038
US 11166947 ↗ Method of use U-3299 Jan 25, 2038
US 9072680 ↗ Drug product — Jun 28, 2032
US 9089496 ↗ Drug product — Jun 28, 2032
US 9089496 ↗ Drug product — Jun 28, 2032
US 9089496 ↗ Drug product — Jun 28, 2032
US 8840924 ↗ Drug product — Jun 5, 2026
US 9072680 ↗ Drug product — Jun 28, 2032
US 9072680 ↗ Drug product — Jun 28, 2032
US 8840924 ↗ Drug product — Jun 5, 2026
US 8840924 ↗ Drug product — Jun 5, 2026
Common questions
Is there a generic version of COTEMPLA XR-ODT 8.6 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for COTEMPLA XR-ODT 8.6 MG TABLET. 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.

🗺️ 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 70165-0100-30, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.4K
Units reimbursed last 4 qtrs
74.6K
Gross reimbursed last 4 qtrs
$1.28M
Avg / prescription
$539.90
Avg / unit
$17.1430
Latest quarter Q4 2025
569Rx
Medicaid pays / ea
$17.1430
gross reimbursed
vs
NADAC / ea
$18.0754
acquisition cost
=
Spread
−$0.9324
-5% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
32% FFS 68% MCO
Fee-for-service · 762 Rx Managed care · 1,608 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 3,082 units · 30.7 per 100k residents MI New York: 5,264 units · 26.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,354 units · 73.4 per 100k residents IA Illinois: no data reported IL Indiana: 9,899 units · 144 per 100k residents IN Ohio: 2,669 units · 22.6 per 100k residents OH Pennsylvania: 2,717 units · 21.0 per 100k residents PA New Jersey: 3,390 units · 36.5 per 100k residents NJ Massachusetts: no data reported MA California: 1,965 units · 5.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 1,710 units · 27.6 per 100k residents MO Kentucky: 1,830 units · 40.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 3,900 units · 63.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 1,461 units · 49.7 per 100k residents KS Arkansas: no data reported AR Tennessee: 2,548 units · 35.8 per 100k residents TN North Carolina: 7,365 units · 68.0 per 100k residents NC South Carolina: 2,610 units · 48.6 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,030 units · 66.2 per 100k residents LA Mississippi: no data reported MS Alabama: 2,820 units · 55.2 per 100k residents AL Georgia: 6,487 units · 58.8 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 9,539 units · 31.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.0144
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 Indiana 144 /100k
2 Iowa 73.4 /100k
3 North Carolina 68.0 /100k
4 Louisiana 66.2 /100k
5 Maryland 63.1 /100k
6 Georgia 58.8 /100k
7 Alabama 55.2 /100k
8 Kansas 49.7 /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 Cotempla XR-ODT — 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 Cotempla XR-ODT. 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
$37.6K
Claims incl. refills
44
Beneficiaries
20
Spend / beneficiary
$1,879.23
Spend / claim
$854.20
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.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Product Quality Issue5,596
Fatigue3,323
Headache3,182
Nausea3,111
Anxiety2,975
Insomnia2,447
Depression2,436

Age at onset

Neonate57
Infant37
Child2,162
Adolescent1,305
Adult4,564
Elderly537

Reporter sex

73,541 reports

Serious outcomes

Hospitalization12,320
Death2,734
Disabling1,384
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,076 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70165-0100-30 You're viewing this 5 BLISTER PACK in 1 CARTON (70165-100-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2017-06-20 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 205 words ▾

WARNING: ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before prescribing COTEMPLA XR-ODT, 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. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.

COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10): • Before prescribing COTEMPLA XR-ODT, 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 167 words ▾

1 INDICATIONS AND USAGE COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ]. Limitations of Use The use of COTEMPLA XR-ODT 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)] .

COTEMPLA XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limitations of Use The use of COTEMPLA XR-ODT 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 Recommended starting dose for pediatric patients 6 to 17 years of age is 17.3 mg given orally once daily in the morning. Dosage may be increased weekly in increments of 8.6 mg to 17.3 mg per day. Daily dosage above 51.8 mg is not recommended. ( 2.2 ) Patients are advised to take COTEMPLA XR-ODT consistently either with food or without food. ( 2.2 )

2.1Pretreatment Screening Prior to treating patients with COTEMPLA XR-ODT, 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 sydrome before initiating COTEMPLA XR-ODT [see Warnings and Precautions (5.10) ].

2.2General Dosing Information COTEMPLA XR-ODT is given orally once daily in the morning. Advise patients to take COTEMPLA XR-ODT consistently either with food or without food [see Clinical Pharmacology (12.3) ] . The recommended starting dose of COTEMPLA XR-ODT for patients 6 to 17 years of age is 17.3 mg once daily in the morning.

The dose may be titrated weekly in increments of 8.6 mg to 17.3 mg. Daily doses above 51.8 mg have not been studied and are not recommended. The dose should be individualized according to the needs and responses of the patient.

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

2.4COTEMPLA XR-ODT Administration Instruct the patient or caregiver on the following administration instructions: Do not remove the tablet from the blister pack until just prior to dosing. Take the tablet immediately after opening the blister pack. Do not store the tablet for future use.

Use dry hands when opening the blister pack. Remove the tablet by peeling back the foil on the blister pack. Do not push the tablet through the foil.

As soon as the blister is opened, remove the tablet and place on the patient's tongue. Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing. The tablet will disintegrate in saliva so that it can be swallowed.

No liquid is needed to take the tablet.

💊 Dosage Forms and Strengths 84 words ▾

3 DOSAGE FORMS AND STRENGTHS 8.6 mg extended-release orally disintegrating tablet: round, purple to light purple mottled (debossed "T1" on one side and plain on the other) 17.3 mg extended-release orally disintegrating tablet: round, purple to light purple mottled (debossed "T2" on one side and plain on the other) 25.9 mg extended-release orally disintegrating tablet: round, purple to light purple mottled (debossed "T3" on one side and plain on the other) Extended-release orally disintegrating tablets: 8.6 mg, 17.3 mg, 25.9 mg.

( 3 )

⛔ Contraindications 110 words ▾

4 CONTRAINDICATIONS COTEMPLA XR-ODT is contraindicated in patients with: Known hypersensitivity to methylphenidate or other components of COTEMPLA XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see Adverse Reactions (6.2) ] . Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor because of the risk of hypertensive crisis [see Drug Interactions (7.1) ] .

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

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS . Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse.

Consider the benefits and risks in patients for whom an increase in blood pressure or heart rate would be problematic. ( 5.3 ) Psychiatric Adverse Reactions : Prior to initiating COTEMPLA XR-ODT, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing COTEMPLA XR-ODT.

( 5.4 ) Priapism : If abnormally sustained or frequent and painful erection occur, patients should seek immediate medical attention. ( 5.5 ) Peripheral Vasculopathy, including Raynaud's Phenomenon : Careful observation for digital changes is necessary during COTEMPLA XR-ODT treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of perifphral vasculophathy.

( 5.6 ) Long-term Suppression of Growth in Pediactric 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 : COTEMPLA XR-ODT-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 COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT has a high potential for abuse and misuse. The use of COTEMPLA XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. COTEMPLA XR-ODT can be diverted for nonmedical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)] .

Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT in a safe place, preferably locked, and instruct patients to not give COTEMPLA XR-ODT to anyone else. Throughout COTEMPLA XR-ODT 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 dosages. Avoid COTEMPLA XR-ODT use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, 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. Moni…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Known hypersensitivity to methylphenidate or other ingredients of Cotempla XR-ODT [see Contraindications (4) ] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , and 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 ) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics, Inc. at 1-888-319-1789 or http://www.COTEMPLAXRODT.com 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 COTEMPLA XR-ODT in Children with ADHD There is limited experience with COTEMPLA XR-ODT in controlled trials. Based on this limited experience, the adverse reaction profile of COTEMPLA XR-ODT appears similar to other methylphenidate extended release-products.

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 purpura Cardiac Disorders : Angina pectoris, Bradycardia, Extrasystole, Supraventricular tachycardia, Ventricular extrasystole Eye Disorders : Diplopia, Increased intraocolar pressure, Mydriasis, Visual impairment General Disorders : Chest pain, Chest discomfort, Hyperpyrexia Immune System Disorders : Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritis NEC, Rashes, Eruptions, and Exanthemas NEC Investigations : Alkaline phosphatase increased, Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blo…

🔄 Drug Interactions ~1 min read ▾

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

7.1Clinically Important Interactions with COTEMPLA XR-ODT Table 1: Drugs Having Clinically Important Interactions with Methylphenidate Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: 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 [see Contraindications (4) ] . Intervention: Do not administer COTEMPLA-XR ODT concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment.

Gastric pH Modulators Clinical Impact: May change the release profile and alter the pharmacodynamics of COTEMPLA-XR ODT. Intervention: Concomitant use of Cotempla XR-ODT with a gastric pH modulator (i.e., a H2-blocker or a proton pump inhibitor) is not recommended. Antihypertensive Drugs Clinical Impact: Cotempla XR-ODT may decrease the effectiveness of drug used to treat hypertension [see Warnings and Precautions (5.3) ].

Intervention: Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical Impact: Concomitant use of halogenated anesthetics and COTEMPLA XR-ODT may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention: Avoid use of COTEMPLA XR-ODT in patients being treated with anesthetics on the day of surgery.

Risperidone Clinical Impact: Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Intervention: Monitor for signs of EPS.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS .

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to COTEMPLA XR-ODT during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes [see Data ] .

There are risks to the fetus associated with the use of central nervous system (CNS) stimulants during pregnancy [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 4 and 18 times, respectively, the maximum recommended human dose (MRHD) of 51.8 mg (as base). However, spina bifida was observed in rabbits at a dose 60 times the MRHD [see Data ].

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

Clinical Considerations Fetal/Neonatal adverse reactions CNS stimulants, such as COTEMPLA XR-ODT, 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 Human Data A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing methylphenidate use during pregnancy.

Due to the small number of methylphenidate-exposed pregnancies with known outcomes, these data cannot definitely establish or exclude any drug-associated risk during pregnancy. Methodological limitations of these observational studies include small sample size, concomitant use of other medications, lack of detail regarding dose and duration of exposure to methylphenidate and non-generalizability of the enrolled populations. 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 60 times the maximum recommended human dose (MRHD) of 51.8 mg (as base) for adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (18 times the MRHD for adolescent 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 (11 times the MRHD on a mg/m 2 basis for adolescent), which was also maternally toxic.

The no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the MRHD on a mg/m 2 basis for adolescent).

8.2Lactation Risk Summary Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COTEMPLA XR-ODT and any potential adverse…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to COTEMPLA XR-ODT during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes [see Data ] .

There are risks to the fetus associated with the use of central nervous system (CNS) stimulants during pregnancy [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 4 and 18 times, respectively, the maximum recommended human dose (MRHD) of 51.8 mg (as base). However, spina bifida was observed in rabbits at a dose 60 times the MRHD [see Data ].

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

Clinical Considerations Fetal/Neonatal adverse reactions CNS stimulants, such as COTEMPLA XR-ODT, 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 Human Data A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing methylphenidate use during pregnancy.

Due to the small number of methylphenidate-exposed pregnancies with known outcomes, these data cannot definitely establish or exclude any drug-associated risk during pregnancy. Methodological limitations of these observational studies include small sample size, concomitant use of other medications, lack of detail regarding dose and duration of exposure to methylphenidate and non-generalizability of the enrolled populations. 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 60 times the maximum recommended human dose (MRHD) of 51.8 mg (as base) for adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (18 times the MRHD for adolescent 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 (11 times the MRHD on a mg/m 2 basis for adolescent), which was also maternally toxic.

The no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the MRHD on a mg/m 2 basis for adolescent).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of COTEMPLA XR-ODT 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 COTEMPLA XR-ODT have been established in pediatric patients 6 to 17 years of age in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methyphenidate-containing products [see Clinical Pharmacology (12) and Clinical Studies (14) ] . Long Term Suppression Growth Growth should be monitored during treatment with stimulants, including COTEMPLA XR-ODT. 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 Toxicity 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) of 51.8 mg (as base) for pediatric patients 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 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day [approximately 6 times the MRHD of 51.8 mg (as base) 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 COTEMPLA XR-ODT 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 104⁰F) and rhabdomyolysis may develop.

Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of COTEMPLA XR-ODT 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. The mode of therapeutic action in ADHD is not known.

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and 1- isomers. The d- isomer is more pharmacologically active than the l -isomer. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

12.3Pharmacokinetics After oral administration of COTEMPLA XR-ODT, circulation levels of l - methylphenidate (MPH) were about 2% of total MPH. Elimination Plasma methylphenidate concentrations decline monophasically following oral administration of COTEMPLA XR-ODT. The mean plasma terminal elimination half-life of methylphenidate was about 4 hours in healthy volunteers following a single 51.8 mg dose administration.

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

The main primary metabolite was PPAA, accounting for approximately 80% of the dose. Absorption Following a single dose of 51.8 mg (2×25.9 mg daily) COTEMPLA XR-ODT in healthy adult subjects under fasted conditions, plasma methylphenidate (MPH) reached maximal concentration (C max ) at a median time of 5 hours after dosing. Compared to an extended release capsule formulation of methylphenidate, methylphenidate mean C max and exposure (AUC inf ) was about 26% and 6% higher, respectively, after COTEMPLA XR-ODT administration (Figure 2).

Figure 2: Mean d- Methylphenidate Plasma Concentration-Time Profiles After Administration of COTEMPLA XR-ODT or Methylphenidate Hydrochloride Extended-Release Capsule in Healthy Volunteers Under Fasted Conditions Figure 2 Effect of Food Administration of 51.8 mg COTEMPLA XR-ODT with food (a high fat meal) decreased the C max and increased AUC inf of total MPH by approximately 24% and 16%, respectively. Food shortened the median time to peak concentration (T max ) by 0.5 hour (fed: 4.5 hours vs. fasted: 5.0 hours). Effect of Alcohol There is no in vivo study conducted for the effect of alcohol on drug exposure.

An in vitro dissolution study showed alcohol-induced dose dumping potential in the presence of 40% alcohol. Dose dumping was not observed in the presence of lower alcohol concentrations. Specific Populations Male and Female Patients and Ethnic Groups There is insufficient experience with the use of COTEMPLA XR-ODT to detect gender or ethnic variations in pharmacokinetics.

Pediatric Patients The pharmacokinetics of methylphenidate after COTEMPLA XR-ODT administration were studied in pediatric patients (6-17 years of age) with ADHD under fasted conditions. After a single oral dose of 51.8 mg COTEMPLA XR-ODT, plasma concentrations of methylphenidate in children (6-12 years of age) were approximately twice the concentrations observed in adults. Exposure levels in adolescent patients (13 -17 years of age) were similar to those in adults.

Body weight normalized clearance values were similar across the age groups (Table 2). Table 2: PK Parameters (Mean ±SD) of d-MPH After 51.8 mg Oral Dosing of COTEMPLA XR-ODT Under Fasted Conditions PK Parameter Children (n=24) Adolescent (n=8) Adult (n=38) T max (hr) † 4.6 (2.0-8.0) 5.31 (3.5-8.0) 4.98 (2.5 – 6.5) T ½ (hr) 4.43±1.0 3.93±0.33 4.00±0.73 C max (ng/mL) 32.7±9.83 20.2±5.79 20.8±5.22 Cl (L/hr/kg) 6.21±1.48 5.54±1.19 5.48±1.46 AUC ∞ (hr*ng/mL) 328.9±90.21 187.2±62.05 169.1±57.13 † data presented as median range Patients with Renal Impairment There is no experience with the use of COTEMPLA XR-ODT in patients with renal insufficiency.

After oral administration of radiolabeled methylphenidate in humans, methylphenidate was ex…

🧬 Mechanism of Action 22 words ▾

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

📦 How Supplied / Storage and Handling 188 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING COTEMPLA XR-ODT Extended Release Orally Disintegrating Tablets are available in three strengths: 8.6 mg tablets, round, purple to light purple, mottled, and debossed "T1" on one side of the tablet; 17.3 mg tablets, round, purple to light purple, mottled, and debossed "T2" on one side of the tablet; 25.9 mg tablets, round, purple to light purple, mottled, and debossed "T3" on one side of the tablet. They are available as follows: NDC 70165-100-30 8.6 mg tablets: carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets with a reusable travel case.

NDC 70165-200-30 17.3 mg tablets: carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets with a reusable travel case. NDC 70165-300-30 25.9 mg tablets: carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets with a reusable travel case. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store COTEMPLA XR-ODT blister packages in the reusable travel case after removal from the carton.

📦 Storage and Handling 37 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store COTEMPLA XR-ODT blister packages in the reusable travel case after removal from the carton.

📋 Description 155 words ▾

11 DESCRIPTION COTEMPLA XR-ODT contains methylphenidate, a central nervous system (CNS) stimulant. COTEMPLA XR-ODT is an extended-release orally disintegrating tablet intended for once daily administration. COTEMPLA XR-ODT contains approximately 25% immediate-release and 75% extended-release methylphenidate.

Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. COTEMPLA XR-ODT contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1.

Figure 1: Methylphenidate Structure C 14 H 19 NO 2 Mol. Wt. 233.31 COTEMPLA XR-ODT also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350.

Figure 1

💬 Information for Patients ~3 min read ▾

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

Instructions for Taking COTEMPLA XR-ODT Instruct patients and their caregivers on the following: The tablet should remain in the blister pack until the patient is ready to take it. The tablet should be taken immediately after opening the blister pack. It should not be stored for future use.

The patient or caregiver should use dry hands when opening the blister pack. The patient or caregiver should remove the tablet by peeling back the foil on the blister pack. The tablet should not be pushed through the foil.

As soon as the blister is opened, the tablet should be removed and placed on the patient's tongue. The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. The tablet will disintegrate in saliva and can be swallowed.

No liquid is needed to take the tablet. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death with COTEMPLA XR-ODT use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ] .

Increased Blood Pressure and Heart Rate Advise patients and their caregivers that COTEMPLA XR-ODT can elevate blood pressure and heart rate [see Warnings and Precautions (5.3) ] . Psychiatric Adverse Reactions Advise patients and their caregivers that COTEMPLA XR-ODT, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history or 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 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 COTEMPLA XR-ODT. 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 COTEMPLA XR-ODT 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 COTEMPLA XR-ODT [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 COTEMPLA XR-ODT. 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 (10)] .

Alcohol Effect Advise patients t…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 09/2025 Medication Guide COTEMPLA XR-ODT (koh-TEM-pluh - oh dee tee) (methylphenidate) extended-release orally disintegrating tablets, CII What is the most important information I should know about COTEMPLA XR-ODT? COTEMPLA XR-ODT may cause serious side effects, including: Abuse, misuse, and addiction .

COTEMPLA XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT or when it is used in ways that are not approved, such as snorting or injection Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before treatment with COTEMPLA XR-ODT and will monitor your child during treatment.

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

Keep COTEMPLA XR-ODT in a safe place and properly dispose of any used medicine. See “ How should I store COTEMPLA XR-ODT? ” for more information. Tell your healthcare provider if your child has 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 your child carefully for heart problems before starting COTEMPLA XR-ODT.

Tell your healthcare provider if your child has any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with COTEMPLA XR-ODT . Increased blood pressure and heart rate.

Your healthcare provider should check your child's blood pressure and heart rate regulary during treatment with COTEMPLA XR-ODT. Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with COTEMPLA XR-ODT, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is COTEMPLA XR-ODT? COTEMPLA XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. COTEMPLA XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in children 6 to 17 years of age with ADHD.

COTEMPLA XR-ODT is not recommended for use in children under 6 years of age with ADHD. COTEMPLA XR-ODT 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 COTEMPLA XR-ODT in a safe place to protect it from theft.

Never give your COTEMPLA XR-ODT to anyone else, because it may cause death or harm them. Selling or giving away COTEMPLA XR-ODT may harm others and is against the law. Do not give COTEMPLA XR-ODT to your child if they are : allergic to methylphenidate or any of the ingredients in COTEMPLA XR-ODT.

See the end of this Medication Guide for a complete list of ingredients in COTEMPLA XR-ODT. taking, or has taken within the past 14 days, a medicine used to treat depres…

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.