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Methylphenidate Hydrochloride 18 mg Tablet, Extended Release, 100-count — NDC 57664-606-88 (Billing 57664-0606-88)

by Sun Pharmaceutical Industries, Inc. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Methylphenidate Hydrochloride 18 mg Tablet, Extended Release from Sun Pharmaceutical Industries, Inc., no longer marketed (first marketed Aug 2020), no longer in the FDA NDC Directory; retail pharmacies pay about $0.7359 per tablet (NADAC). It is this product's only package size.

NDC 57664-0606-88

🏷️ FDA NDC (as labeled) 57664-606-88 billing pads the product segment with a zero

Rx only Generic Discontinued CII ⚠ On shortage ⚠ Discontinued by firm ⇄ Compare with another NDC

🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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

⚠️

Active FDA shortage. Methylphenidate Hydrochloride Tablet, Extended Release is currently reported in shortage by the FDA (Discontinuation of the manufacture of the drug). Unavailable Shortage details →

⚠️

Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Feb 7, 2022 — Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind. (RISING PHARMACEUTICALS) · FDA recall D-0573-2022

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

⚠️

Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57664-606-88

Product NDC 57664-606

11-digit billing NDC 57664060688

NCPDP billing unit EA — each (per item)

RxCUI 1091155, 1091170, 1091185, 1091210

UNII 4B3SC438HI

Application # ANDA205135

SPL Set ID d048e52d-7406-4fc1-9a72-c073bafc7439

Established class (EPC) Central Nervous System Stimulant

Physiologic effect Central Nervous System Stimulation

DEA schedule CII

Marketing category ANDA

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Oct 2023)

Marketing start 2020-08-20

Route ORAL

Dosage form TABLET, EXTENDED RELEASE

Substance METHYLPHENIDATE HYDROCHLORIDE

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

GPI-14 61400020100460

GPI class Methylphenidate HCl ER (OSM)

GCN Seq No 045981

GCN 12567

HICL code 001682

Ingredient (HICL) Methylphenidate Hcl

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H2

Therapeutic class — intermediate (HIC2) Psychoactive Drugs

HIC3 code H2V

Therapeutic class — specific (HIC3) Tx For Attention Deficit-Hyperact(Adhd)/Narcolepsy

AHFS code 28:20.32.00

AHFS class Respiratory And Cns Stimulants

FDB label name METHYLPHENIDATE ER 18 MG TAB

FDB brand name Methylphenidate Er

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 045981
GCN: 12567
GPI-14 (Medi-Span): 61400020100460
HICL (First Databank): 001682
AHFS class code: 28:20.32.00
RxCUI (RxNorm): 1091155

Why two NDCs? The FDA registers this code as 57664-606-88 — 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 → 57664-0606-88. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant

Drug family (ATC) Centrally acting sympathomimetics

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name METHYLPHENIDATE ER 18 MG TAB Ingredient Methylphenidate Hcl

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It mainly treats ADHD, and some products are also used for narcolepsy. The exact approval depends on the product and the age group. Your prescriber chooses the right one for you.
It depends on your product. Many extended-release forms are taken once daily in the morning, while Jornay PM is taken in the evening. Swallow extended-release tablets whole, and fo...
The most common ones are decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety and dizziness. Children and teens may get upper stomach pain. Call your doctor i...
Call for chest pain, fainting, a racing heartbeat, hallucinations, seizures, painful erections that won’t go away, or color changes in your fingers or toes. Also call if you notice...

📖 Read our full Methylphenidate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Methylphenidate Hydrochloride — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Methylphenidate Hydrochloride (85 interactions) — ranked by severity →

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.736	$73.59 / 100 tablets
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$2.92	$292.47 / 100 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 11% over the last 15 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.

CMS NADAC weekly file · file of Feb 21, 2024
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
57664-0606-88 You're viewing this Main listing	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	2020-08-20	—	Discontinued by firm

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Methylphenidate Hydrochloride 18 mg 50268-0545-12	AvPAK	1 tablet	$0.576	AB	Discontinued	save 22%
Methylphenidate Hydrochloride 18 mg 13811-0706-10	Trigen	100 tablets	$0.576	AB	Availability likely	save 22%
Methylphenidate Hydrochloride 18 mg 31722-0952-01	Camber	100 tablets	$0.576	AB	Availability likely	save 22%
Methylphenidate Hydrochloride 18 mg 60687-0532-21	American	1 tablet	$0.576	AB	Availability likely	save 22%
Methylphenidate Hydrochloride 18 mg 62037-0725-01	Actavis	100 tablets	$0.576	AB	Availability likely	save 22%
Methylphenidate Hydrochloride 18 mg 62175-0310-37	Lannett	100 tablets	$0.576	BX	Availability likely	save 22%
Methylphenidate Hydrochloride 18 mg 00527-3310-37	Lannett	100 tablets	$0.736	AB	FDA listed	—
Methylphenidate Hydrochloride 18 mgthis 57664-0606-88	Sun	100 tablets	$0.736	—	Discontinued	—
Relexxii 18 mg 68025-0095-10	Vertical	100 tablets	$10.945	—	Availability likely	+1387%
Concerta 18 mg 50458-0585-01	Janssen	100 tablets	$12.325	AB	Availability likely	+1575%
Methylphenidate Hydrochloride 18 mg 51407-0924-01	Golden	100 tablets	—	AB	FDA listed	—
Methylphenidate Hydrochloride 18 mg 72865-0133-01	XLCare	100 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file · file of Feb 21, 2024

Availability & generic status

🏛️

2020

On the market since

Aug 2020

📍

2026

Currently FDA-listed

6 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

FDA Orange Book · refreshed Sep 3, 2026

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerSun Pharmaceutical Industries, Inc.

Application holderSUN PHARMACEUTICAL INDUSTRIES INC

FDA applicationANDA205135 (ANDA)

Labeler code57664

First marketedAug 2020

DEA scheduleCII

Product typeHuman Prescription Drug

Portfolio890 products on file

🔎 All NDCs from Sun Pharmaceutical Industries, Inc.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 Methylphenidate hydrochloride extended-release tablets have 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 methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10)] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of methylphenidate hydrochloride extended-release tablets, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.1, 9.2)]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.

Methylphenidate hydrochloride extended-release tablets have 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 methylphenidate hydrochloride extended-release tablets, can result in overdose and death (5.1, 9.2, 10) : Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of methylphenidate hydrochloride extended-release tablets, 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 Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].

Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. (1) Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage (5.7, 8.4).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Prior to initiating methylphenidate hydrochloride extended-release tablets treatment assess for (2.1): o the presence of cardiac disease o for family history of tics or Tourette’ syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. (2.2) Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate hydrochloride extended-release tablets: starting dosage is 18 mg once daily.

May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients (2.3): o 6 to 12 years: 54 mg once daily o 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate hydrochloride extended-release tablets: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily.

(2.3) Patients currently using immediate-release methylphenidate: starting methylphenidate hydrochloride extended-release tablets dosage is based on current dosage regimen. (2.4)

2.1Pretreatment Screening Prior to treating patients with methylphenidate hydrochloride extended-release tablets, assess: For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)]. The family history for tics or Tourette’ syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions (5.11)].

2.2Important Administration Instructions Administer methylphenidate hydrochloride extended-release tablets orally once daily in the morning with or without food. Swallow methylphenidate hydrochloride extended-release tablets whole with liquids. Do not split, crush, or chew the extended-release tablets because doing so will compromise the extended-release characteristics of methylphenidate hydrochloride extended-release tablets and may compromise the effectiveness or safety of methylphenidate hydrochloride extended-release tablets.

2.3Recommended Methylphenidate Hydrochloride Extended-Release Tablets Dosage in Patients New to Methylphenidate See Table 1 for the recommended once-daily dosage of methylphenidate hydrochloride extended-release tablets inpatients who were not taking a methylphenidate product. In patients who have not achieved an optimal response at a lower dosage, increase the methylphenidate hydrochloride extended-release tablets dosage in 18 mg increments at weekly intervals. However, if a slower titration is recommended for patients who have not achieved an optimal response taking 18 mg of methylphenidate hydrochloride extended-release tablets once daily, increase their daily dosage to 27 mg once per day.

Table 1. Recommended Methylphenidate Hydrochloride Extended-Release Tablets Dosage in Patients New to Methylphenidate Patient Population Recommended Starting Dosage Dosage Range Pediatric patients 6 to 12 years of age 18 mg once daily 18 mg to 54 mg once daily Pediatric patients 13 to 17 years of age 18 mg once daily 18 mg to 72 mg once daily (not to exceed 2 mg/kg/day) Adults 18 to 65 years of age 18 or 36 mg once daily 18 mg to 72 mg once daily

2.4Recommended Methylphenidate Hydrochloride Extended-Release Tablets Dosage in Patients Switching from Another Methylphenidate Product See Table 2 for the recommended starting dosage of methylphenidate hydrochloride extended-release tablets in patients switching from an immediate-release methylphenidate product administered twice daily or three times daily (total daily dosage of 10 to 60 mg/day). Table 2. Recommended Starting Dosage in Patients Switching from Another Methylphenidate Product * Only for patients 12-65 years of age.

In patients who have not achieved an optimal response at a lower dosage, increase the methylphenidate hydrochloride extended-release tablet… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 133 words ▾

3 DOSAGE FORMS AND STRENGTHS Methylphenidate hydrochloride extended-release tablets, USP are available in the following dosage strengths: 18 mg: Cylindrical shaped, yellow colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "18". 27 mg: Cylindrical shaped, grey colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "27". 36 mg: Cylindrical shaped, white colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "36".

54 mg: Cylindrical shaped, brownish red colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "54". Extended-release tablets: 18, 27, 36, and 54 mg ( 3 )

⛔ Contraindications 109 words ▾

4 CONTRAINDICATIONS Methylphenidate hydrochloride extended-release tablets are contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate hydrochloride extended-release tablets. [see Adverse Reactions (6)]. Receiving concomitant monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with a MAO inhibitor because of the risk of a hypertensive crisis [see Drug Interactions (7)].

Known hypersensitivity to methylphenidate or other components of the methylphenidate hydrochloride extended-release tablets (4) Receiving concomitant monoamine oxidase inhibitors and within 14 days following discontinuation of treatment with a MAO inhibitor (4)

⚠️ Warnings and Cautions ~2 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 methylphenidate hydrochloride extended-release tablets, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release tablets. (5.4) Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention (5.5) Peripheral Vasculopathy, including Raynaud’s Phenomenon: Carefully assess for digital changes during methylphenidate hydrochloride extended-release tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy (5.6) Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients.

Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. (5.7) Risk of Gastrointestinal (GI) Obstruction in Patients with GI Narrowing: Only use in patients able to swallow the extended-release tablet whole, and should not ordinarily be used in patients with pre-existing severe GI narrowing. (5.8) Acute Angle Closure Glaucoma : Methylphenidate hydrochloride extended-release tablets-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

(5.9) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe methylphenidate hydrochloride extended-release tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma. (5.10) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome : Before initiating methylphenidate hydrochloride extended-release tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.

Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. (5.11)

5.1Abuse, Misuse, and Addiction Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse. The use of methylphenidate hydrochloride extended-release tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction [see Drug Abuse and Dependence (9.1, 9.2)]. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher dosage or unapproved methods of administration, such as snorting or injection.

Before prescribing methylphenidate hydrochloride extended-release tablets, 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 methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else.

Throughout methylphenidate hydrochloride extended-release tablets 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 car… [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), Drug Abuse and Dependence (9.2)] Hypersensitivity Reactions [see Contraindications (4)] Monoamine Oxidase Inhibitors [see Contraindications (4), Drug Interactions (7)] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)] Priapism [see Warnings and Precautions (5.5)] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.6)] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7)] Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing [see Warnings and Precautions (5.8)] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9)] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10)] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.11)] The most common adverse reactions (≥5%) in double-blind clinical trials were: • Pediatric patients 6 to 17 years: upper abdominal pain.

(6.1) • Adults up to 65 years of age: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial 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 clinical trials of another drug and may not reflect the rates observed in clinical practice. The data below is based on a total of 3,906 patients in clinical studies who received methylphenidate hydrochloride extended-release tablets. Patients aged 6 up to 65 years old with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies [see Table 3] .

Table 3: Methylphenidate Hydrochloride Extended-Release Tablets-treated Patients in Double-Blind and Open- Label Clinical Studies Patient Population N Dosage Range Pediatric patients 6 to 12 years of age 2,216 18 to 54 mg once daily Adolescents 502 18 to 72 mg once daily Adults up to 65 years of age 1,188 18 to 108 mg once daily The most common adverse reactions (≥5%) in double-blind clinical trials were: • Pediatric patients: upper abdominal pain [see Table 4]. • Adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis [see Table 5].

The most common adverse reactions associated with methylphenidate hydrochloride extended-release tablets discontinuation (≥1%) from the pediatric and adult clinical trials were anxiety, irritability, insomnia, and increased blood pressure. Most Common Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials: Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations. Adverse Reactions in Pediatric Patients Aged 6 years and Older Table 4 displays adverse reactions reported in 2% or more of methylphenidate hydrochloride extended-release tablets - treated pediatric patients ages 6 and older with ADHD in 4 placebo-controlled, double-blind clinical trials.

Table 4. Most Common Adverse Reactions 1 in Pediatric Patients 6 Years of Age and Older with ADHD in 4 Placebo-Controlled, Double-Blind Clinical Trials 1 Reported in ≥ 2% of methylphenidate hydrochloride extended-release tablets-treated patients 2 Initial insomnia (methylphenidate hydrochloride extended-release tablets =0.6%) and insomnia (methylphenidate hydrochloride extended-release… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 6 describes clinically significant drug interactions with methylphenidate hydrochloride extended-release tablets. Table 6: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [see Contraindications (4)]. Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can cause hypertensive crisis.

Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) methylphenidate hydrochloride extended-release tablets may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3].

Halogenated Anesthetics Prevention or Management Avoid use of methylphenidate hydrochloride extendedrelease tablets in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of halogenated anesthetics and methylphenidate hydrochloride extended-release tablets may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms.

Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant methylphenidate hydrochloride extended-release tablets when there is a change in the methylphenidate hydrochloride extended-release tablets or risperidone dosage. Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed.

(7) See additional clinically significant drug interactions, in the DRUG INTERACTIONS section (7).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Caution should be exercised if administered to nursing mothers (8.3) Safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age (8.4 and 8.5)

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

There are risks to the fetus associated with the use of central nervous system (CNS) stimulants during pregnancy (see Clinical Considerations). No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults.

A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data). The background risk of major birth defects and miscarriage in those with ADHD is unknown.

All pregnancies have a background risk of birth defects, 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 methylphenidate hydrochloride extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion.

No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine dependent mothers. Data Animal In embryo-fetal development studies conducted in rats and rabbits, methylphenidate hydrochloride extended-release tablets were administered orally at doses up to 30 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis.

The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis).

When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offs… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day, given to adults on a mg/m 2 basis). The no effect level f… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride extended-release tablets for the treatment of ADHD have been established in pediatric patients 6 years of age and older. The safety and effectiveness of methylphenidate hydrochloride extended-release tablets 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. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored in pediatric patients during treatment with CNS stimulants, including methylphenidate hydrochloride extended-release tablets.

Pediatric patients who are not growing or gaining weight as expected may need to have their methylphenidate hydrochloride extended-release tablets treatment interrupted [see Warnings and Precautions (5.7)]. Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only.

The doses at which these findings were observed are at least 4 times the MRHD of 54 mg/day given to pediatric patients 6 to 12 years of age on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 54 mg/day given to pediatric patients 6 to 12 years of age 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 (9 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis).

The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis). The clinical significance of the longterm behavioral effects observed in rats is unknown.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use Methylphenidate hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age.

🆘 Overdosage 127 words ▾

10 OVERDOSAGE

10.1Clinical 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.

10.2Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of methylphenidate hydrochloride extended-release tablets should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of inin ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been fully characterized.

12.3Pharmacokinetics Absorption Following oral administration of methylphenidate hydrochloride extended-release tablets, plasma methylphenidate concentrations reached an initial maximum concentration at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours, after which a gradual decrease begins. Mean times to reach peak plasma concentrations across all doses of methylphenidate hydrochloride extended-release tablets occurred between 6 and 10 hours. Methylphenidate hydrochloride extended-release tablets once daily minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate three times daily [see Figure 1] .

No clinically significant difference in methylphenidate exposures was observed following the administration of either methylphenidate hydrochloride extended-release tablets once daily and immediate-release methylphenidate three times daily in adults. Figure 1. Mean Methylphenidate Plasma Concentrations Following a Single 18 mg Methylphenidate hydrochloride Extended-release Tablets 18 mg dose and Immediate-release Methylphenidate 5 mg Doses (Three Doses Administered Every 4 Hours) The mean single-dose pharmacokinetic parameters in 36 healthy adults following the administration of one 18 mg methylphenidate hydrochloride extended-release tablet dose and three 5 mg methylphenidate doses every four hours are summarized in Table 7.

Table 7: Methylphenidate Pharmacokinetic Parameters (Mean ± SD) After Methylphenidate Hydrochloride Extended-release Tablets and Immediate-release Methylphenidate Dosing in Healthy Adults The methylphenidate pharmacokinetics were evaluated in healthy adults following single- and multiple-doses (steady state) of methylphenidate hydrochloride extended-release tablets (up to 144 mg/day (up to 2 times the maximum recommended dose)). The mean half-life was about 3.6 hours. No differences in the pharmacokinetics of methylphenidate hydrochloride extended-release tablets were noted following single and repeated once-daily methylphenidate hydrochloride extended-release tablet dosing, indicating no significant drug accumulation.

The AUC and t½ following repeated once-daily dosing are similar to those following a single 18 to 144 mg dose of methylphenidate hydrochloride extended-release tablets. Dose Proportionality Following administration of methylphenidate hydrochloride extended-release tablets in single doses of 18, 36, and 54 mg/day to healthy adults, Cmax and AUC (0-inf) of d-methylphenidate were dose proportional, whereas l-methylphenidate C max and AUC (0-inf) increased disproportionately with respect to dose. Following administration of methylphenidate hydrochloride extended-release tablets, plasma concentrations of the l-isomer were approximately 1/40 the plasma concentrations of the d-isomer.

In healthy adults, single and multiple doses (once-daily) methylphenidate hydrochloride extended-release tablets doses from 54 to 144 mg/day resulted in linear and dose-proportional increases in C max and AUC inf for total methylphenidate (MPH) and its major metabolite, α-phenyl-piperidine acetic acid (PPAA). There was no time dependency in the pharmacokinetics of methylphenidate. The rati… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 52 words ▾

📦 How Supplied / Storage and Handling 194 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate hydrochloride extended-release tablets, USP are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. All four dosage strengths are supplied in bottles containing 100 tablets. 18 mg: Cylindrical shaped, yellow colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "18".

NDC 57664-606-88 100 count CRC bottle 27 mg: Cylindrical shaped, grey colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "27". NDC 57664-607-88 100 count CRC bottle 36 mg: Cylindrical shaped, white colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "36". NDC 57664-608-88 100 count CRC bottle 54 mg: Cylindrical shaped, brownish red colored coated tablets, with presence of one aperture on one of the base side of the cylinder and imprinted with "54".

NDC 57664-609-88 100 count CRC bottle Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

📋 Description 185 words ▾

11 DESCRIPTION Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect.

Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl, USP is a white, odorless crystalline powder.

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

Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide.

The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP. Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride extended-release tablets, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1, 9.2), Overdosage (10)]. Advise patients to store methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else.

Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate hydrochloride extended-release tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)]. Increased Blood Pressure and Heart Rate Advise patients and their caregivers that methylphenidate hydrochloride extended-release tablets can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3)].

Psychiatric Risks Advise patients and their caregivers that methylphenidate hydrochloride extended-release tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)]. Priapism Advise patients, caregivers, and family members of methylphenidate hydrochloride extended-release tablets-treated males of the possibility of priapism. Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].

Peripheral Vasculopathy, including Raynaud’s Phenomenon Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms; to report to their health care provider any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes; to call their health care provider immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release tablets [see Warnings and Precautions (5.6)].

Long-term Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)] . Glaucoma and Increased Intraocular Pressure Advise patients that increased intraocular pressure and glaucoma may occur during methylphenidate hydrochloride extended-release tablets treatment [see Warnings and Precautions (5.10)] . 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 methylphenidate hydrochloride extended-release tablets treatment.

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 (5.11)]. Administration Instructions Instruct patients to swallow methylphenidate hydrochloride extended-release tablets whole with liquids, and not to split, crush, or chew, the extended-release tablets. Advise patients not to be concerned if they occasionally notice a tablet-appearing substance in their stool.

Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to methylphenidate hydrochloride extended-release tablets during pregnancy [see Use in Specific Populations (8.1)]. Lactation Advise methylphenidate hydrochloride extended-release tablets-treated breastfeeding women to moni… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~2 min read ▾

Medication Guide MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Tablets, USP, for oral use, CII (meth" ǝl-fen 'i-dāt) What is the most important information I should know about methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of methylphenidate hydrochloride extended-release tablets, 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 methylphenidate hydrochloride extended-release tablets 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 methylphenidate hydrochloride extended-release tablets and will monitor you or your child during treatment.

Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give methylphenidate hydrochloride extended-release tablets to anyone else. See “What are methylphenidate hydrochloride extended-release tablets?” for more information.

Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate hydrochloride extended-release tablets?” 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 methylphenidate hydrochloride extended-release tablets.

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 methylphenidate hydrochloride extended-release tablets. Increased blood pressure and heart rate.

Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release tablets. Mental (psychiatric) problems, including: new or worse behavior or 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 methylphenidate hydrochloride extended-release tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. See “What are the possible side effects of methylphenidate hydrochloride extended-release tablets?” for more information about side effects. What are methylphenidate hydrochloride extended-release tablets?

Methylphenidate hydrochloride extended-release tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 to 65 years of age. Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

In healthy adults, single and multiple doses (once-daily) methylphenidate hydrochloride extended-release tablets doses from 54 to 144 mg/day resulted in linear and dose-proportional increases in C max and AUC inf for total methylphenidate (MPH) and its major metabolite, α-phenyl-piperidine acetic acid (PPAA). There was no time dependency in the pharmacokinetics of methylphenidate. The ratio of metabolite (PPAA) to parent drug (MPH) was constant across doses from 54 to 144 mg/day, both after single dose and upon multiple dosing.

In a multiple-dose study, after patients aged 13 to 16 with ADHD were administered their prescribed methylphenidate hydrochloride extended-release tablet dose (18 to 72 mg/day), mean C max and AUC TAU of d- and total methylphenidate increased proportionally with respect to dose. Food Effects: In patients, there were no differences in either the pharmacokinetics or the pharmacodynamic performance of methylphenidate hydrochloride extended-release tablets when administered after a high-fat breakfast. Distribution Plasma methylphenidate concentrations in adults and adolescents decline biexponentially followin… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 46 words ▾

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Overview of Clinical Trials Methylphenidate hydrochloride extended-release tablets were demonstrated to be effective in the treatment of ADHD in patients who met the Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD in the following trials: Three trials in pediatric patients 6 to 12 years old (Studies 1, 2, and 3), One trial in adolescents (13 to 18 years old), Two trials in adults (18 to 65 years old).

14.2Clinical Trials in Pediatric Patients 6 to 12 Years Three double-blind, active- and placebo-controlled trials were conducted in 416 pediatric patients 6 to 12 years of age with ADHD: (1) two single-center, crossover trials (patients received each treatment for one week) (Studies 1 and 2) and (2) a multicenter, 4-week, parallel-group comparison trial (Study 3). In these trials, patients were randomized to receive: 18 mg, 36 mg, or 54 mg of oral methylphenidate given once daily, 5 mg, 10 mg, or 15 mg of oral immediate-release methylphenidate given three times daily (15, 30, or 45 mg total daily dosage) over 12 hours, and Placebo The primary comparison of interest in all three trials was the methylphenidate group versus the placebo group.

ADHD symptoms were evaluated by community schoolteachers using the Inattention/Overactivity with Aggression (IOWA) Conners scale. A statistically significant reduction in the Inattention/Overactivity subscale (0 to 15) in the methylphenidate group versus the placebo group was shown in all three trials. The scores for methylphenidate hydrochloride extended-release tablets and placebo for the three trials are presented in Figure 2.

Figure 2. Mean Community School Teacher Inattention/Overactivity Subscores in the IOWA Conners Scale in Pediatric Patients 6 to 12 Years with ADHD Studies 1 and 2 involved a 3-way crossover of 1-week per treatment arm. Study 3 involved 4 weeks of parallel-group treatments with a Last Observation Carried Forward analysis at week 4.

Error bars represent the mean plus standard error of the mean. In Studies 1 and 2, symptoms of ADHD including attentiveness were evaluated by schoolteachers using the Swanson, Kotkin, Agler, M-Fynn, and Pelham (SKAMP) laboratory school rating scale. The combined results from these two trials demonstrated statistically significant improvements in attention and behavior in the methylphenidate group compared to the placebo group.

These results were maintained through 12 hours after dosing. Figure 3 presents the schoolteacher SKAMP ratings for the methylphenidate and placebo groups in Studies 1 and 2. Figure 3.

School Teacher SKAMP Ratings (Mean (SEM) of Combined Attention) in Pediatric Patients 6 to 12 Years with ADHD (Studies 1 and 2) Figure Figure

14.3Clinical Trials in Pediatric Patients 13 to 17 Years In a randomized-withdrawal, double-blind, multicenter, placebo-controlled trial (Study 4) with 177 pediatric patients 13 to 17 years of age with ADHD, methylphenidate demonstrated effectiveness with a dosage up to 72 mg/day (1.4 mg/kg/day): Of 220 patients who entered an open 4-week titration phase, 177 patients were titrated to an individualized methylphenidate dosage (maximum of 72 mg/day) based on meeting specific improvement criteria on the ADHD Rating Scale and the Global Assessment of Effectiveness with acceptable tolerability.

Patients who met these criteria were then randomized to receive either their individualized dosage of methylphenidate (18 to 72 mg/day, n=87) or placebo (n=90) during a two-week double-blind phase. At the end of the double blind phase, mean scores for the investigator rating on the ADHD Rating Scale demonstrated that the methylphenidate group was statistically significantly superior to the placebo group.

14.4Clinical Trials in Adults up to 65 Years Old Two randomized double-blind, placebo-controlled multicenter, parallel-group trials were conducted in 627 adults aged 18 to 65 years with ADHD who received methylphenidate or placebo once daily: Study 5 was a 7-week… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~3 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Methylphenidate hydrochloride extended-release tablets contain methylphenidate, a Schedule II controlled substance.

9.2Abuse Methylphenidate hydrochloride extended-release tablets have 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)]. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain.

Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Studies of Abuse Potential with methylphenidate hydrochloride extended-release tablets In two placebo- and active-controlled, crossover human abuse potential (HAP) studies, the relative abuse potential of single oral doses of methylphenidate hydrochloride extended-release tablets were compared to single oral doses of immediate-release methylphenidate (IR MPH) and placebo in subjects with a history of recreational CNS stimulant use.

In these studies, the response for each of the abuse-related subjective measures was defined as the maximum effect within the first 8 hours after treatment administration. When evaluating these results, consider that 22% of the total methylphenidate amount in methylphenidate hydrochloride extended-release tablets (methylphenidate hydrochloride) extended-release tablets is available for immediate release and the remaining 78% is available for extended-release over 24 hours. In the first HAP study (n=40), single dose administration of methylphenidate hydrochloride extended-release tablets 108 mg (1.5 times the maximum recommended adult dose of methylphenidate hydrochloride extended-release tablets), IR MPH 60 mg (2 times the maximum recommended adult dose of IR MPH), or placebo were administered to subjects in a cross-over design.

Methylphenidate hydrochloride extended-release tablets 108 mg and IR MPH 60 mg produced responses on the subjective measures of Drug Liking and Abuse Potential that were statistically similar, and both were statistically significantly greater than the responses to placebo. However, on subjective measures of Euphoria, methylphenidate hydrochloride extended-release tablets 108 mg produced responses that were statistically less than those produced by IR MPH 60 mg. In the second HAP study (n=49), a single dose of methylphenidate hydrochloride extended-release tablets 108 mg (1.5 times the maximum recommended adult dose of methylphenidate hydrochloride extended-release tablets), methylphenidate hydrochloride extended-release tablets 54 mg (0.75 times the maximum recommended adult dose of methylphenidate hydrochloride extended-release tablets), IR MPH 90 mg (3 times the maximum recommended adult dose of IR MPH), 50 mg (1.7 times the maximum recommended adult dose of IR MPH),… [Excerpted — this section continues on DailyMed.]

🔒 Controlled Substance 14 words ▾

9.1Controlled Substance Methylphenidate hydrochloride extended-release tablets contain methylphenidate, a Schedule II controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

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

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increases 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 6 times the MRHD (adults) on a mg/m 2 basis.

In a 24-week carcinogenicity study 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 concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or the in vitro mouse lymphoma cell forward mutation assay.

Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study.

The study was conducted at doses up to 160 mg/kg/day, approximately 11 times the MRHD of methylphenidate hydrochloride extended-release tablets given to adults on a mg/kg and mg/m 2 basis.

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

The study was conducted at doses up to 160 mg/kg/day, approximately 11 times the MRHD of methylphenidate hydrochloride extended-release tablets given to adults on a mg/kg and mg/m 2 basis.

📄 Recent Major Changes 31 words ▾

Indications and Usage (1) 9/2025 Dosage and Administration (2.3, 2.4) 2/2026 Warnings and Precautions: Long-Term Suppression of Growth in Pediatric Patients 9/2025 Warnings and Precautions: Removal Seizures and Hematologic Monitoring 2/2026

📄 Package Label / Principal Display Panel 20 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PDP-18mg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PDP-27mg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PDP-36mg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PDP-54mg

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

cardiomyopathy: A disease of the heart muscle that makes it harder for the heart to pump blood.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

controlled substance: A medicine regulated by law because it can be misused or lead to dependence, with special rules for prescribing and storage.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

euphoria: An intense feeling of happiness or well-being that is stronger than a normal good mood.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

extrapyramidal symptoms: Movement problems caused by certain medicines, such as stiffness, tremor, restlessness, or unusually slow movements.

fertility: The natural ability to become pregnant or to father a child.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertensive crisis: A dangerous, sudden rise in blood pressure to very high levels.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intraocular pressure: The fluid pressure inside the eye.

IOP: The fluid pressure inside the eye.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolite: A new substance formed when the body breaks a medicine down.

misuse: Using a medicine differently from how it was prescribed or directed, whether on purpose or by mistake.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

physical dependence: When the body adapts to a medicine over time, so stopping it suddenly causes uncomfortable symptoms.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vasoconstriction: Narrowing of blood vessels, which reduces blood flow through them and can raise blood pressure.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

About this NDC listing & data coverage

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

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	✓ Available
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Who lists this product with the FDA?

Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

← 57664-0596-50 · Sun 57664-0607-88 · Sun →

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.

Methylphenidate Hydrochloride 18 mg Tablet, Extended Release, 100-count — NDC 57664-606-88 (Billing 57664-0606-88)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

Full prescribing information FDA SPL

10 OVERDOSAGE

12 CLINICAL PHARMACOLOGY

14 CLINICAL STUDIES

9 DRUG ABUSE AND DEPENDENCE

13 NONCLINICAL TOXICOLOGY

About this NDC listing & data coverage

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