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AZSTARYS Serdexmethylphenidate and Dexmethylphenidate 52.3 mg; 10.4 mg Capsule, 100-count — NDC 65038-0561-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AZSTARYS Serdexmethylphenidate and Dexmethylphenidate 52.3 mg; 10.4 mg Capsule, 100-count — NDC 65038-561-99 (Billing 65038-0561-99)

by Commave Sub, LLC · 100 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 100 capsules of AZSTARYS Serdexmethylphenidate and Dexmethylphenidate 52.3 mg; 10.4 mg Capsule from Commave Sub, LLC, marketed since Jul 2021 and currently FDA-listed; retail pharmacies pay about $14.41 per capsule (NADAC). It is this product's only package size.

NDC 65038-0561-99
🏷️ FDA NDC (as labeled) 65038-561-99 billing pads the product segment with a zero
Rx only Brand On market CII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 65038-561-99 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65038 labeler · 561 product · 99 package
Package marketed since
Jul 16, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC)
0365038561993, 0365038429996, 0365038286995
Medicaid fills, this package
61,787 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65038-561-99
Product NDC 65038-561
11-digit billing NDC 65038056199
NCPDP billing unit EA — each (per item)
RxCUI 2562186, 2562187, 2562191, 2562194, 2562199, 2562204
UNII FN54BT298Y, 1678OK0E08
UPC 0365038561993, 0365038429996, 0365038286995
Application # NDA212994
SPL Set ID 00b5e716-5564-4bbd-acaf-df2bc45a5663
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 2021-07-16
Route ORAL
Dosage form CAPSULE
Substance SERDEXMETHYLPHENIDATE CHLORIDE; DEXMETHYLPHENIDATE HYDROCHLORIDE

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

GPI-14 61409802800140
GPI class Azstarys
GCN Seq No 082024
GCN 49323
HICL code 047187
Ingredient (HICL) Serdexmethylphen/Dexmethylphen
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 AZSTARYS 52.3 MG-10.4 MG CAP
FDB brand name Azstarys
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082024
  • GCN: 49323
  • GPI-14 (Medi-Span): 61409802800140
  • HICL (First Databank): 047187
  • AHFS class code: 28:20.32.00
  • RxCUI (RxNorm): 2562186
Why two NDCs? The FDA registers this code as 65038-561-99 — 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 → 65038-0561-99. 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 Centrally acting sympathomimetics class.

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

Clinical

Label name AZSTARYS 52.3 MG-10.4 MG CAP Ingredient Serdexmethylphen/Dexmethylphen
📖 What it is MedlinePlus · NLM

The combination of serdexmethylphenidate and dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children 6 years of age and older. The combination of serdexmethylphenidate and dexmethylphenidate is in a class of medications called central nervous system stimulants. These medications work by changing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Azstarys is a prescription stimulant approved to treat ADHD in people 6 and older. It works by boosting two brain chemicals — dopamine and norepinephrine — that are involved in att...
  • What exactly does Azstarys do, and why was I prescribed it?
  • Yes — Azstarys capsules can be opened and the contents sprinkled into 2 tablespoons of applesauce or 50 mL of water. Just make sure to consume the whole mixture right away, within...
  • Can I open the capsule if I (or my child) have trouble swallowing it?
📖 Read our full Serdexmethylphenidate and Dexmethylphenidate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 $14.413 $1,441.26 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $13.95 $1,394.97 / 100 capsules
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
Jan 2024 May 2026 Jul 2026 Sep 2026 $14.456 $13.362
▲ Up 8% over the last 7 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65038-0561-99 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE, PLASTIC 2021-07-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Azstarys 52.3 mg/1; 10.4 mgthis 65038-0561-99 Commave 100 capsules $14.413 — Availability likely —
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

🏛️
2021
First FDA approval
May 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2037
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 Dec 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 7, 2021 RLD RS ⏳ ~11.2 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 10858341 — method of use (U-3094)
US 10954213 — method of use (U-3094)
US 10858341 — method of use (U-3094)
US 10954213 — method of use (U-3094)
US 10954213 — method of use (U-3094)
US 10858341 — method of use (U-3094)
US 10584112 — drug substance
US 10584112 — drug substance
US 10584113 — drug product
US 10759778 — drug product
US 9079928 — drug product
US 9079928 — drug product
US 10759778 — drug product
US 10584113 — drug product
US 9079928 — drug product
US 10759778 — drug product
US 10584113 — drug product
US 10584112 — drug substance
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
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 (18)
PatentTypeUse codeExpires
US 10858341 ↗ Method of use U-3094 Dec 9, 2037
US 10954213 ↗ Method of use U-3094 Dec 9, 2037
US 10858341 ↗ Method of use U-3094 Dec 9, 2037
US 10954213 ↗ Method of use U-3094 Dec 9, 2037
US 10954213 ↗ Method of use U-3094 Dec 9, 2037
US 10858341 ↗ Method of use U-3094 Dec 9, 2037
US 10584112 ↗ Drug substance — Dec 9, 2037
US 10584112 ↗ Drug substance — Dec 9, 2037
US 10584113 ↗ Drug product — Dec 9, 2037
US 10759778 ↗ Drug product — Dec 9, 2037
US 9079928 ↗ Drug product — May 7, 2035
US 9079928 ↗ Drug product — May 7, 2035
US 10759778 ↗ Drug product — Dec 9, 2037
US 10584113 ↗ Drug product — Dec 9, 2037
US 9079928 ↗ Drug product — May 7, 2035
US 10759778 ↗ Drug product — Dec 9, 2037
US 10584113 ↗ Drug product — Dec 9, 2037
US 10584112 ↗ Drug substance — Dec 9, 2037
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)May 7, 2026
NCENew Chemical Entity (5-year)May 7, 2026
NCENew Chemical Entity (5-year)May 7, 2026
Common questions
Is there a generic version of AZSTARYS 52.3 MG-10.4 MG CAP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for AZSTARYS 52.3 MG-10.4 MG CAP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2037 — 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.

What it looks like

Color gray / blue / orange
ShapeCapsule
ImprintKP415;5612
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

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

  • 6.67 mg 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 1.34 mg 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.
  • 54.64 mg 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.
  • 1.33 mg 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.
  • 1.33 mg UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerCommave Sub, LLC
Application holderCOMMAVE SUB LLC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC
FDA applicationNDA212994 (NDA)
Labeler code65038
First marketedJul 2021
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Commave Sub, LLC labeler code 65038

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

Full prescribing information FDA SPL

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

WARNING: ABUSE, MISUSE, AND ADDICTION AZSTARYS 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 AZSTARYS, 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 AZSTARYS, 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 AZSTARYS 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.

AZSTARYS 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 AZSTARYS, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing AZSTARYS, 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 AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS 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 )]. AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

( 1 ) Limitations of Use The use of AZSTARYS 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 Pediatric Patients 6 to 12 years : Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week. Maximum recommended dosage is 52.3 mg/10.4 mg once daily.

( 2.2 ) Adults and Pediatric Patients 13 to 17 years: Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Increase the dosage after one week to 52.3 mg/10.4 mg once daily depending on response and tolerability. ( 2.2 ) Administer with or without food.

( 2.3 ) Swallow capsules whole or open and sprinkle onto applesauce or add to water. ( 2.3 ) To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis. ( 2.4 )

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

2.2Recommended Dosage Pediatric Patients 6 to 12 years of age The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning. The dosage may be increased after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, or decreased after one week to a dosage of 26.1 mg serdexmethylphenidate/5.2 mg dexmethylphenidate per day, depending on response and tolerability. Maximum recommended dosage is 52.3 mg serdexmethylphendiate/10.4 mg dexmethyphenidate once daily.

Adults and Pediatric Patients 13 to 17 years of age The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning. Increase the dosage after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, depending on response and tolerability. Maximum recommended dosage is 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate once daily.

2.3Administration Instructions Administer AZSTARYS orally once daily in the morning with or without food [see Clinical Pharmacology ( 12.3 )] . AZSTARYS capsules may be taken whole, or opened and the entire contents sprinkled into 50 mL of water or over 2 tablespoons of applesauce. Consume all the drug/food mixture immediately or within 10 minutes of mixing; do not store for future use [see Clinical Pharmacology ( 12.3 )] .

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

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

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS AZSTARYS capsules are available as: 26.1 mg/5.2 mg (serdexmethylphenidate/dexmethylphenidate) – blue cap/grey body, imprinted with "286" on cap and "KP415" on the body 39.2 mg/7.8 mg (serdexmethylphenidate/dexmethylphenidate) – dark blue cap/grey body, imprinted with "429" on cap and "KP415" on the body 52.3 mg/10.4 mg (serdexmethylphenidate/dexmethylphenidate) – orange cap/grey body, imprinted with "5612" on cap and "KP415" on the body Capsules (serdexmethylphenidate/dexmethylphenidate): 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg.

( 3 )

⛔ Contraindications 120 words ▾

4 CONTRAINDICATIONS AZSTARYS is contraindicated in patients: with known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of AZSTARYS. Bronchospasm, rash, and pruritus have been reported in patients who received AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions ( 6.2 )] . receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis [see Drug Interactions ( 7.1 )] .

Known hypersensitivity to serdexmethylphenidate, 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. (5.3) Psychiatric Adverse Reactions : Prior to initiating AZSTARYS, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing AZSTARYS. (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 AZSTARYS treatment with ADHD stimulants.

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 : Monitor height and weight at appropriate intervals in pediatric patients. (5.7) Acute Angle Closure Glaucoma : AZSTARYS-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 AZSTARYS 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 AZSTARYS, 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 AZSTARYS has a high potential for abuse and misuse. The use of AZSTARYS exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. AZSTARYS 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 AZSTARYS, 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 AZSTARYS, 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 AZSTARYS in a safe place, preferably locked, and instruct patients to not give AZSTARYS to anyone else. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid AZSTARYS 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 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Some patients may have larger increases. Monitor all AZSTARYS-treated patients for hypertension and tachycardia.

5.4Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , and Drug Abuse and Dependence (9.2 , 9.3) ] Known hypersensitivity to methylphenidate or other ingredients of AZSTARYS [see Contraindications (4) ] Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4) ] 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 Corium, LLC at 1-855-253-2407 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 Pediatric Patients and Adults with ADHD Commonly reported (≥ 5% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia.

Adverse Reactions in Studies with AZSTARYS in Pediatric Patients (6 to 12 years) with ADHD Short-Term Study A short-term study conducted in pediatric patients 6 to 12 years of age with ADHD was comprised of a 3-week, open-label, dose optimization phase in which all patients received AZSTARYS (n=155), followed by a 1-week, double-blind, controlled phase in which patients were randomized to continue AZSTARYS (n=74) or switch to placebo (n=76). Because of the study design, the reported adverse reaction rates cannot be used to predict the rates that may be expected in clinical practice.

Long-Term Study A long-term, open-label safety study was conducted in pediatric patients 6 to 12 years of age with ADHD who either completed the short-term study or were de novo patients. This study was comprised of a 3-week dose optimization phase for patients not recently treated with AZSTARYS followed by a 12-month treatment phase for all patients during which 238 patients received open- label AZSTARYS and had evaluable safety data. A total of 154 patients were treated for 12 months.

Because of the open-label, uncontrolled design of this study, the reported adverse reaction rates cannot be assessed in terms of a causal relationship to AZSTARYS treatment. To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]); z- scores normalize for the natural growth of children and adolescents by comparisons to age- and sex-matched population standards. A z-score change less than

0.5SD is considered not clinically significant. In this study, the mean increase in weight from baseline t… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.1 )

7.1Clinically Important Interactions with AZSTARYS Table 1 presents clinically important drug interactions with AZSTARYS. Table 1: Clinically Important Drug Interactions with AZSTARYS Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including AZSTARYS, 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 AZSTARYS concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment [see Contraindications ( 4 )] Antihypertensive Drugs Clinical Impact AZSTARYS may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] . Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug, as needed. Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and AZSTARYS may increase the risk of sudden blood pressure and heart rate increase during surgery.

Intervention Avoid use of AZSTARYS in patients being treated with anesthetics on the day of surgery. Risperidone Clinical Impact Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Intervention Monitor for signs of EPS.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including AZSTARYS, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary There are no available data on AZSTARYS use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; however, AZSTARYS contains dexmethylphenidate and serdexmethylphenidate, a prodrug of dexmethylphenidate.

Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy ( see Clinical Considerations ).

Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 3 times the maximum recommended human dose (MRHD) of 40 mg/day dexmethylphenidate hydrochloride given to adults based on plasma levels. A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of dexmethylphenidate to rats throughout pregnancy and lactation at doses 3 times the MRHD of 40 mg/day dexmethylphenidate hydrochloride given to adults based on plasma levels ( see Data ).

No evidence of developmental effects were found in an embryo-fetal development study with oral administration of serdexmethylphenidate to rabbits during organogenesis at doses up to approximately 49 times the MRHD of 52 mg/day serdexmethylphenidate given to adults based on plasma levels ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as AZSTARYS, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate hydrochloride was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate hydrochloride was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed.

At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 3 and 1 times, respectively, those in adults dosed with 40 mg/day dexmethylphenidate hydrochloride. Racemic methylphenidate hydrochloride has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. No evidence of developmental effects were found in an embryo-fetal development study with oral administration of serdexmethylphenidate in rabbits during organogenesis at doses of up to 374 mg/kg/day.

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

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including AZSTARYS, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary There are no available data on AZSTARYS use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; however, AZSTARYS contains dexmethylphenidate and serdexmethylphenidate, a prodrug of dexmethylphenidate.

Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy ( see Clinical Considerations ).

Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 3 times the maximum recommended human dose (MRHD) of 40 mg/day dexmethylphenidate hydrochloride given to adults based on plasma levels. A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of dexmethylphenidate to rats throughout pregnancy and lactation at doses 3 times the MRHD of 40 mg/day dexmethylphenidate hydrochloride given to adults based on plasma levels ( see Data ).

No evidence of developmental effects were found in an embryo-fetal development study with oral administration of serdexmethylphenidate to rabbits during organogenesis at doses up to approximately 49 times the MRHD of 52 mg/day serdexmethylphenidate given to adults based on plasma levels ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as AZSTARYS, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate hydrochloride was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate hydrochloride was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed.

At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 3 and 1 times, respectively, those in adults dosed with 40 mg/day dexmethylphenidate hydrochloride. Racemic methylphenidate hydrochloride has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. No evidence of developmental effects were found in an embryo-fetal development study with oral administration of serdexmethylphenidate in rabbits during organogenesis at doses of up to 374 mg/kg/day.

At the highest dose tested, the p… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of AZSTARYS 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 AZSTARYS have been established in pediatric patients ages 6 to 17 years of age for the treatment of ADHD. Use of AZSTARYS in patients 6 to 12 years of age is supported by a randomized, double-blind, placebo-controlled, parallel group trial in 155 pediatric patients with ADHD and a 12-month open-label long term safety trial in 238 patients [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14 )]. Use of AZSTARYS in pediatric patients 13 to 17 years of age is supported by additional pharmacokinetics analysis showing similar plasma concentration-time profiles of dexmethylphenidate in adolescents and adults after administration of the same dose of AZSTARYS [see Clinical Studies ( 14 )].

Long Term Suppression of Growth Growth should be monitored during treatment with stimulants, including AZSTARYS. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions ( 5.7 ) and Adverse Reactions ( 6.1 )] . Juvenile Animal Toxicity Data Rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood.

A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 3 times the MRHD of 40 mg/day dexmethylphenidate hydrochloride given to children on a mg/m 2 basis. In a study conducted in young rats, racemic methylphenidate hydrochloride 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 racemic methylphenidate hydrochloride [approximately 3 times the maximum recommended human dose (MRHD) of 40 mg of dexmethylphenidate hydrochloride given to children on a mg/m 2 basis] or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (6 times the MRHD of 40 mg of dexmethylphenidate hydrochloride given to children on a mg/m 2 basis).

The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day racemic methylphenidate hydrochloride (less than the MRHD of 40 mg of dexmethylphenidate hydrochloride given to children on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown. Serdexmethylphenidate was administered orally to juvenile rabbits at doses up to 280 mg/kg/day (approximately 50 times the MRHD of 52 mg/day serdexmethylphenidate given to children on a mg/m 2 basis), respectively, for 6 months, starting at postnatal Day 28 and continuing through sexual maturity (postnatal Day 196).

No adverse findings were observed at the highest dose of serdexmethylphenidate.

🧓 Geriatric Use 17 words ▾

8.5Geriatric Use Clinical trials of AZSTARYS did not include any patients aged 65 years and over.

🆘 Overdosage 122 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 AZSTARYS 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 Serdexmethylphenidate is a prodrug of dexmethylphenidate. Dexmethylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

12.2Pharmacodynamics Dexmethylphenidate Dexmethylphenidate is the more pharmacologically active d-enantiomer of racemic d,l- methylphenidate. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. In vitro studies with serdexmethylphenidate showed little or no binding of the prodrug to monoaminergic reuptake transporters.

Cardiac Electrophysiology The effect of serdexmethylphenidate on QTc interval was evaluated in a randomized, double-blind, placebo-controlled, human abuse potential study (intranasal administration) in 46 healthy subjects. At a mean concentration 40 times the C max for the highest dose of AZSTARYS (52.3/10.4 mg base equivalent), serdexmethylphenidate does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Serdexmethylphenidate is a prodrug of dexmethylphenidate. Following a single dose administration of 52.3 mg/10.4 mg AZSTARYS and 40 mg of an dexmethylphenidate hydrochloride extended-release (ER) capsule in healthy volunteers under fasted conditions: The mean peak plasma concentration (C max ) of dexmethylphenidate was 14.0 ng/mL and 28.2 ng/mL, respectively; The mean area under concentration curve (AUC) of dexmethylphenidate was 186 hour*ng/mL and 248 hour*ng/mL, respectively. The plasma PK profiles of dexmethylphenidate following administration of AZSTARYS or dexmethylphenidate hydrochloride extended-release (ER) capsule are presented in Figure 1 .

Figure 1: Mean Dexmethylphenidate Plasma Concentration-Time Profiles After A Single Dose Administration of AZSTARYS or Dexmethylphenidate Hydrochloride Extended-Release (ER) Capsule in Healthy Adults Under Fasted Conditions Approximate linear PK was demonstrated for dexmethylphenidate following single dose administration of AZSTARYS in the dose range of 26.1 mg/5.2 mg to 52.3 mg/10.4 mg. Steady state of dexmethylphenidate was approached after the third once-daily dose. At steady-state, dexmethylphenidate mean exposures (C max and AUC 0-24h ) were approximately 37% higher relative to a single-dose administration of AZSTARYS.

No accumulation of serdexmethylphenidate was observed after once-daily administration of AZSTARYS. The mean relative exposure of serdexmethylphenidate to dexmethylphenidate based on molar concentrations for C max , C min , and AUC 0-24hr was about 101%, 8.5%, and 55.7%, respectively, following multiple once-daily oral dosing under fasted conditions. Absorption Cross-study calculation estimated an absolute oral bioavailability for serdexmethylphenidate of less than 3%.

The median time to reach C max of serdexmethylphenidate and dexmethylphenidate (T max ) is about 2 hours following a single dose administration of AZSTARYS under fasted conditions. Following oral administration of serdexmethylphenidate single moiety alone, dexmethylphenidate T max is reached at about 8 hours post dose. Effect of Food No clinically meaningful differences in the exposure of dexmethylphenidate were observed when administered after an overnight fast, with a high-fat, high-caloric meal, or sprinkled onto applesauce or water.

The median time to peak plasma concentration (T max ) was lengthened from 2 to 4-4.5 hours in the presence of food. Distribution Plasma protein binding of serdexmethylphenidate and dexmethylphenidate is approximately 56% and 47%, respectively, at 5 µM (about 60-fold higher than the therapeutic concentrations at the highest recommended dose). The mean apparent volume of distribution for serdexmethylphenidate was about

29.3L/kg after AZSTARYS administration. Dexmethylphenidate shows a mean volume of distribution of

2.65L/kg after intravenous administration. Elimination The m… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 29 words ▾

12.1Mechanism of Action Serdexmethylphenidate is a prodrug of dexmethylphenidate. Dexmethylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

📦 How Supplied / Storage and Handling 116 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AZSTARYS (serdexmethylphenidate/dexmethylphenidate) capsules are available as follows: 26.1 mg/5.2 mg Capsules – blue cap/grey body, imprinted with "286" on cap and "KP415" on the body Bottles of 100 ................................................................... NDC 65038-0286-99 39.2 mg/7.8 mg Capsules – dark blue cap/grey body, imprinted with "429" on cap and "KP415" on the body Bottles of 100 ................................................................... NDC 65038-0429-99 52.3 mg/10.4 mg Capsules – orange cap/grey body, imprinted with "5612" on cap and "KP415" on the body Bottles of 100 ...................................................................

NDC 65038-0561-99 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

📋 Description ~1 min read ▾

11 DESCRIPTION AZSTARYS (serdexmethylphenidate and dexmethylphenidate) capsules contain dexmethylphenidate, a CNS stimulant, and serdexmethylphenidate, a prodrug of dexmethylphenidate. AZSTARYS capsules are intended for oral administration and each capsule contains a fixed molar ratio of 30% dexmethylphenidate and 70% serdexmethylphenidate. AZSTARYS contains 26.1/5.2, 39.2/7.8, or 52.3/10.4 mg of serdexmethylphenidate/ dexmethylphenidate (equivalent to 28/6, 42/9, or 56/12 mg of serdexmethylphenidate chloride/ dexmethylphenidate hydrochloride, respectively.

The combined molar dose of serdexmethylphenidate and dexmethylphenidate in each dosage strength of AZSTARYS is equivalent to 20, 30, or 40 mg dexmethylphenidate hydrochloride, respectively (equivalent to 17.3, 25.9 or 34.6 mg dexmethylphenidate free base, respectively). The chemical name of serdexmethylphenidate chloride is 3-((( 1S )-1-carboxy-2-hydroxyethyl)carbamoyl)-1-(((( 2R )-2-(2-( 1R )-methoxy-2-oxo-1-phenylethyl)piperidine-1-carbonyl)oxy)methyl)pyridinium chloride. Its molecular formula is C 25 H 30 N 3 O 8 + •Cl - , and its structural formula is: Serdexmethylphenidate chloride is a white to off-white crystalline powder.

Its solutions are acid to litmus. It is freely soluble in water, soluble in methanol, and slightly soluble in alcohol and acetone. Its molecular weight is 535.98 g/mol.

Dexmethylphenidate is the d-threo enantiomer of racemic d,l -methylphenidate hydrochloride. The chemical name of dexmethylphenidate hydrochloride is methyl ( R )-2-phenyl-2-(( R )-piperidin-2-yl)acetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl, and its structural formula is: Dexmethylphenidate hydrochloride is a white to off-white powder.

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

Inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and talc. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 26.1/5.2 mg: Black Iron Oxide, FD&C Blue No. 1, Titanium Dioxide 39.2/7.8 mg: Black Iron Oxide, FD&C Blue No.

1, FD&C Red No. 40, Titanium Dioxide 52.3/10.4 mg: Black Iron Oxide, FD&C Red No. 40, FD&C Yellow No.

6, Titanium Dioxide chemical structure-1 chemical structure-2

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

Risk to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with AZSTARYS 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 AZSTARYS can elevate blood pressure and heart rate [see Warnings and Precautions ( 5.3 )] .

Psychiatric Adverse Reactions Advise patients and their caregivers that AZSTARYS, 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 and their caregivers 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 AZSTARYS.

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 and their caregivers that AZSTARYS 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 AZSTARYS [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 AZSTARYS. 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 )] . Administration Instructions Advise patients and their caregivers to administer AZSTARYS capsules whole or opened and sprinkled over applesauce or added to water.

If sprinkled, advise patients and their caregivers to consume all the drug/food mixture immediately or within 10 minutes of mixing and not to store for future use [see Dosage and Administration ( 2.3 )]. Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to AZSTARYS during pregnancy [see Use in Specific Populations ( 8.1 )] . Lactation Advise nursing mother to monitor infants exposed to AZSTARYS through breastmilk for agitation, poor feeding, and reduced weight gain [see Use in Specific Populations ( 8.2 )] .

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💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 09/2025 REF-02399 09/2025 Medication Guide AZSTARYS® (az star’ is) (serdexmethylphenidate and dexmethylphenidate) capsules, CII What is the most important information I should know about AZSTARYS?

AZSTARYS can cause serious side effects, including: Abuse misuse, and addiction. AZSTARYS has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of AZSTARYS, 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 AZSTARYS 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 AZSTARYS and will monitor you or your child during treatment. AZSTARYS may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.

Do not give AZSTARYS to anyone else. See “What is AZSTARYS?” for more information. Keep AZSTARYS in a safe place and properly dispose of any unused medicine.

See “How should I store AZSTARYS?” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease.

Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with AZSTARYS. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with AZSTARYS. Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with AZSTARYS.

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 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 during treatment with AZSTARYS, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is AZSTARYS? AZSTARYS is a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

AZSTARYS is not recommended for use in children under 6 years of age with ADHD. AZSTARYS is a federally controlled substance (CII) because it contains dexmethylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep AZSTARYS in a safe place to protect it from theft.

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

See the end of this Medication Guide for a complete list of ingredients in AZSTARYS. taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). Before taking AZSTARYS, tell y… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Serdexmethylphenidate is a prodrug of dexmethylphenidate. Following a single dose administration of 52.3 mg/10.4 mg AZSTARYS and 40 mg of an dexmethylphenidate hydrochloride extended-release (ER) capsule in healthy volunteers under fasted conditions: The mean peak plasma concentration (C max ) of dexmethylphenidate was 14.0 ng/mL and 28.2 ng/mL, respectively; The mean area under concentration curve (AUC) of dexmethylphenidate was 186 hour*ng/mL and 248 hour*ng/mL, respectively. The plasma PK profiles of dexmethylphenidate following administration of AZSTARYS or dexmethylphenidate hydrochloride extended-release (ER) capsule are presented in Figure 1 .

Figure 1: Mean Dexmethylphenidate Plasma Concentration-Time Profiles After A Single Dose Administration of AZSTARYS or Dexmethylphenidate Hydrochloride Extended-Release (ER) Capsule in Healthy Adults Under Fasted Conditions Approximate linear PK was demonstrated for dexmethylphenidate following single dose administration of AZSTARYS in the dose range of 26.1 mg/5.2 mg to 52.3 mg/10.4 mg. Steady state of dexmethylphenidate was approached after the third once-daily dose. At steady-state, dexmethylphenidate mean exposures (C max and AUC 0-24h ) were approximately 37% higher relative to a single-dose administration of AZSTARYS.

No accumulation of serdexmethylphenidate was observed after once-daily administration of AZSTARYS. The mean relative exposure of serdexmethylphenidate to dexmethylphenidate based on molar concentrations for C max , C min , and AUC 0-24hr was about 101%, 8.5%, and 55.7%, respectively, following multiple once-daily oral dosing under fasted conditions. Absorption Cross-study calculation estimated an absolute oral bioavailability for serdexmethylphenidate of less than 3%.

The median time to reach C max of serdexmethylphenidate and dexmethylphenidate (T max ) is about 2 hours following a single dose administration of AZSTARYS under fasted conditions. Following oral administration of serdexmethylphenidate single moiety alone, dexmethylphenidate T max is reached at about 8 hours post dose. Effect of Food No clinically meaningful differences in the exposure of dexmethylphenidate were observed when administered after an overnight fast, with a high-fat, high-caloric meal, or sprinkled onto applesauce or water.

The median time to peak plasma concentration (T max ) was lengthened from 2 to 4-4.5 hours in the presence of food. Distribution Plasma protein binding of serdexmethylphenidate and dexmethylphenidate is approximately 56% and 47%, respectively, at 5 µM (about 60-fold higher than the therapeutic concentrations at the highest recommended dose). The mean apparent volume of distribution for serdexmethylphenidate was about

29.3L/kg after AZSTARYS administration. Dexmethylphenidate shows a mean volume of distribution of

2.65L/kg after intravenous administration. Elimination The mean plasma terminal elimination half-life of serdexmethylphenidate and dexmethylphenidate in healthy adult subjects was about 5.7 hours and 11.7 hours, respectively, following a single dose of 52.3 mg/10.4 mg AZSTARYS. The mean apparent clearance for serdexmethylphenidate was about

3.6L/hr/kg after AZSTARYS administration. Dexmethylphenidate was eliminated with a mean clearance of

0.40L/hr/kg after intravenous administration. Metabolism Serdexmethylphenidate is a prodrug of dexmethylphenidate and is likely converted to dexmethylphenidate mainly in the lower gastrointestinal tract. Enzymes involved in the conversion process are not identified.

Dexmethylphenidate is metabolized primarily via de-esterification to d -α-phenyl-piperidine acetic acid (also known as d -ritalinic acid). Ritalinic acid has little or no pharmacological activity. There is no in vivo interconversion to the l-threo -enantiomer observed.

Excretion After oral dosing of radiolabeled serdexmethylphenidate in humans, about 62% and 37% of the radioactivity was recovered in urine and feces, respectively. Met… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 111 words ▾

12.2Pharmacodynamics Dexmethylphenidate Dexmethylphenidate is the more pharmacologically active d-enantiomer of racemic d,l- methylphenidate. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. In vitro studies with serdexmethylphenidate showed little or no binding of the prodrug to monoaminergic reuptake transporters.

Cardiac Electrophysiology The effect of serdexmethylphenidate on QTc interval was evaluated in a randomized, double-blind, placebo-controlled, human abuse potential study (intranasal administration) in 46 healthy subjects. At a mean concentration 40 times the C max for the highest dose of AZSTARYS (52.3/10.4 mg base equivalent), serdexmethylphenidate does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Pediatric Patients 6 to 12 years of age with ADHD The efficacy of AZSTARYS for the treatment of ADHD in pediatric patients 6 to 12 years of age was evaluated in a randomized, double-blind, placebo-controlled, parallel group, analog classroom study (Study 1; NCT# 03292952). That study was conducted in 150 pediatric patients 6 to 12 years of age who met Diagnostic and Statistical Manual of Mental Disorders, 5 th edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

Following washout of previous ADHD medication, subjects entered an open-label dose- optimization period (3 weeks) with an initial dosage of 39.2 mg/7.8 mg once daily in the morning. The dose could be titrated on a weekly basis to either 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg, until an optimal dose or the maximum dosage of 52.3 mg/10.4 mg/day was reached. At the end of optimization period, subjects were randomly assigned into a 1-week parallel group treatment period to receive either the individually optimized dose of AZSTARYS (mean dose of 45.6 mg/9.0 mg) or placebo.

At the end of the 1-week treatment period, raters evaluated the attention and behavior of the subjects in a laboratory classroom setting over a period of 13 hours using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. SKAMP is a validated 13-item teacher-rated scale that assesses manifestations of ADHD in a classroom setting. On this day, the dose was administered in the morning immediately after breakfast.

The primary efficacy endpoint was the mean change from baseline (pre-dose at randomization visit) of the SKAMP-Combined scores averaged across the test day (not including baseline score), with assessments conducted at 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post-dose. The mean change from baseline in the SKAMP-Combined scores, averaged across the test day, was statistically significantly lower (indicating improvement) with AZSTARYS compared to placebo ( Table 2 ). Table 2: Primary Efficacy Measure: SKAMP-Combined Scores Averaged Over Classroom Day in Pediatric Patients (6 to 12 years) with ADHD SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval. * Baseline score assessed at pre-dose on the practice classroom day/randomization visit after 2 days of active drug washout. † Classroom day least-squares mean change from baseline over hours 0.5.

1, 2, 4, 8, 10, 12, and 13. ‡ Difference (active drug minus placebo) in least-squares mean change from baseline. Study Number Treatment Group N Mean Baseline Score* (SD) LS Mean Change from Baseline† (SE) Placebo-subtracted Difference‡ (95% CI) Study 1 AZSTARYS (26.1 /5.2, 39.2/7.8, 52.3/10.4 mg/day) 74 17.9 (9.2) -4.87 (0.62) -5.4 (-7.1, -3.7) Placebo 76 17.9 (10.4) 0.54 (0.70) Figure 2: LS Mean Change in SKAMP-Combined Score from Baseline after Treatment with AZSTARYS or Placebo during Classroom Day in Pediatric Patients (6 to 12 years) with ADHD Adults and Pediatric Patients 13 to 17 years of age with ADHD The efficacy of 52.3 mg/10.4 mg AZSTARYS in adults and pediatric patients 13 to 17 years of age was established by pharmacokinetic bridging between AZSTARYS (52.3 mg/10.4 mg) and dexmethylphenidate hydrochloride extended-release capsules [see Clinical Pharmacology ( 12.3 )].

Figure 2

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance AZSTARYS contains dexmethylphenidate hydrochloride, a Schedule II controlled substance, and serdexmethylphenidate, a Schedule IV controlled substance.

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

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

Misuse and abuse of the combination of dexmethylphenidate and serdexmethylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

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

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

🔒 Controlled Substance 19 words ▾

9.1Controlled Substance AZSTARYS contains dexmethylphenidate hydrochloride, a Schedule II controlled substance, and serdexmethylphenidate, a Schedule IV controlled substance.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime studies to evaluate the carcinogenic potential of serdexmethylphenidate have not been conducted. Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate hydrochloride. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas was seen at a daily dose of approximately 60 mg/kg/day.

This dose is approximately 4 times the MRHD of 40 mg of dexmethylphenidate hydrochloride on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors.

The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Racemic methylphenidate hydrochloride did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 5 times the MRHD of 40 mg of dexmethylphenidate hydrochloride on a mg/m 2 basis. In a 24-week carcinogenicity study with racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity.

Male and female mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60 to 74 mg/kg/day of racemic methylphenidate hydrochloride. Mutagenesis Serdexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mammalian cell micronucleus assay using human peripheral blood lymphocytes, in the in vivo rat bone barrow micronucleus assay, or in the in vivo rat alkaline comet assay. Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vivo mouse bone marrow micronucleus test.

In an in vitro assay using cultured Chinese Hamster Ovary (CHO) cells treated with racemic methylphenidate, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response. Impairment of Fertility Racemic methylphenidate hydrochloride did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 10-times the MRHD of 40 mg of dexmethylphenidate hydrochloride on a mg/m 2 basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime studies to evaluate the carcinogenic potential of serdexmethylphenidate have not been conducted. Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate hydrochloride. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas was seen at a daily dose of approximately 60 mg/kg/day.

This dose is approximately 4 times the MRHD of 40 mg of dexmethylphenidate hydrochloride on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors.

The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Racemic methylphenidate hydrochloride did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 5 times the MRHD of 40 mg of dexmethylphenidate hydrochloride on a mg/m 2 basis. In a 24-week carcinogenicity study with racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity.

Male and female mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60 to 74 mg/kg/day of racemic methylphenidate hydrochloride. Mutagenesis Serdexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mammalian cell micronucleus assay using human peripheral blood lymphocytes, in the in vivo rat bone barrow micronucleus assay, or in the in vivo rat alkaline comet assay. Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vivo mouse bone marrow micronucleus test.

In an in vitro assay using cultured Chinese Hamster Ovary (CHO) cells treated with racemic methylphenidate, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response. Impairment of Fertility Racemic methylphenidate hydrochloride did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 10-times the MRHD of 40 mg of dexmethylphenidate hydrochloride on a mg/m 2 basis.

📄 Recent Major Changes 17 words ▾

RECENT MAJOR CHANGES Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.7 ) 09/2025

📄 Package Label / Principal Display Panel 57 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 65038-286-99 - 26.1/5.2 mg 100 count Bottle Label 26 mg 100 count Bottle Label

PRINCIPAL DISPLAY PANEL - NDC: 65038-429-99 - 39.2/7.8 mg 100 count Bottle Label 39 mg 100 count Bottle Label

PRINCIPAL DISPLAY PANEL - NDC: 65038-561-99 - 52.3/10.4 mg 100 count Bottle Label 52 mg 100 count Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – 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
61.8K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$25.64M
Avg / prescription
$415.03
Avg / unit
$13.9497
Latest quarter Q4 2025
15.1KRx
Medicaid pays / ea
$13.9497
gross reimbursed
vs
NADAC / ea
$14.4126
acquisition cost
=
Spread
−$0.4629
-3% 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 ⓘ
33% FFS 67% MCO
Fee-for-service · 20,104 Rx Managed care · 41,683 Rx
State Medicaid map
Alaska: 2,767 units · 377 per 100k residents AK Maine: 4,050 units · 290 per 100k residents ME Washington: 3,919 units · 50.2 per 100k residents WA Idaho: 22,973 units · 1,170 per 100k residents ID Montana: 1,651 units · 146 per 100k residents MT North Dakota: no data reported ND Minnesota: 5,943 units · 104 per 100k residents MN Wisconsin: 18,090 units · 306 per 100k residents WI Michigan: 71,394 units · 711 per 100k residents MI New York: 50,616 units · 259 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,312 units · 165 per 100k residents NH Oregon: 330 units · 7.8 per 100k residents OR Nevada: 2,600 units · 81.4 per 100k residents NV Wyoming: 2,762 units · 473 per 100k residents WY South Dakota: 20,301 units · 2,209 per 100k residents SD Iowa: 60,164 units · 1,876 per 100k residents IA Illinois: 13,243 units · 106 per 100k residents IL Indiana: 253,258 units · 3,691 per 100k residents IN Ohio: 87,502 units · 742 per 100k residents OH Pennsylvania: 53,491 units · 413 per 100k residents PA New Jersey: 6,775 units · 72.9 per 100k residents NJ Massachusetts: 14,669 units · 210 per 100k residents MA California: 27,423 units · 70.4 per 100k residents CA Utah: 11,505 units · 337 per 100k residents UT Colorado: 8,726 units · 148 per 100k residents CO Nebraska: 15,824 units · 800 per 100k residents NE Missouri: 4,334 units · 69.9 per 100k residents MO Kentucky: 117,211 units · 2,590 per 100k residents KY West Virginia: 19,553 units · 1,105 per 100k residents WV Virginia: 29,468 units · 338 per 100k residents VA Maryland: 16,465 units · 266 per 100k residents MD Connecticut: 35,530 units · 982 per 100k residents CT Rhode Island: 7,681 units · 701 per 100k residents RI Arizona: 8,319 units · 112 per 100k residents AZ New Mexico: no data reported NM Kansas: 16,223 units · 552 per 100k residents KS Arkansas: 4,424 units · 144 per 100k residents AR Tennessee: 95,559 units · 1,341 per 100k residents TN North Carolina: 139,440 units · 1,287 per 100k residents NC South Carolina: 32,379 units · 603 per 100k residents SC Delaware: 8,349 units · 810 per 100k residents DE Oklahoma: 4,534 units · 112 per 100k residents OK Louisiana: 174,959 units · 3,825 per 100k residents LA Mississippi: 13,318 units · 453 per 100k residents MS Alabama: 96,904 units · 1,897 per 100k residents AL Georgia: 69,074 units · 626 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 135,391 units · 444 per 100k residents TX Florida: 46,904 units · 207 per 100k residents FL
Units reimbursed · per 100k residents
7.83,825
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 Louisiana 3,825 /100k
2 Indiana 3,691 /100k
3 Kentucky 2,590 /100k
4 South Dakota 2,209 /100k
5 Alabama 1,897 /100k
6 Iowa 1,876 /100k
7 Tennessee 1,341 /100k
8 North Carolina 1,287 /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 Azstarys — 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 Azstarys. 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
$538.1K
Claims incl. refills
1.2K
Beneficiaries
546
Spend / beneficiary
$985.59
Spend / claim
$448.07
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.
← 65038-0429-99 · Commave 65044-0010-01 · Jubilant →
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.