HomeNDC LookupIngredientsDextroamphetamine Sulfate › 11534-0189-01
DEXTROAMPHETAMINE SULFATE 10 mg Tablet, 100-count — NDC 11534-0189-01 package photo

DEXTROAMPHETAMINE SULFATE 10 mg Tablet, 100-count

by SUNRISE PHARMACEUTICAL, INC. · 100 TABLET in 1 BOTTLE (11534-189-01)
NDC 11534-0189-01
🏷️ FDA NDC (as labeled) 11534-189-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.3782 NADAC Per package$37.82 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.5935/unit · Part D plans $0.8511/unit — full pricing hub ↓
Rx only Generic On market CII
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 11534-189-01
Product NDC 11534-189
11-digit billing NDC 11534018901
NCPDP billing unit EA — each (per item)
RxCUI 884385, 884386
UNII JJ768O327N
UPC 0311534189032, 0311534188035
Application # ANDA210059
SPL Set ID 93b3a40f-b7ac-4047-8ff5-3e34c2d75193
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-04
Route ORAL
Dosage form TABLET
Substance DEXTROAMPHETAMINE SULFATE
GCN Seq No 005009
GCN 19880
HICL code 002065
Ingredient (HICL) Dextroamphetamine Sulfate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5B
Therapeutic class — specific (HIC3) Adrenergics, Aromatic, Non-Catecholamine
AHFS code 28:20.04.00
AHFS class Amphetamines
FDB label name DEXTROAMPHETAMINE 10 MG TAB
FDB brand name Dextroamphetamine Sulfate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 11534-189-01 — 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 → 11534-0189-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

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

🏭 Manufacturer & labeler

LabelerSUNRISE PHARMACEUTICAL, INC.
Application holderNUVO PHARMACEUTICAL INC
FDA applicationANDA210059 (ANDA)
Labeler code11534
First marketedJul 2018
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio26 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DEXTROAMPHETAMINE 10 MG TAB Ingredient Dextroamphetamine Sulfate
📖 What it is MedlinePlus · NLM

Dextroamphetamine is used 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) and to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Dextroamphetamine is in a class of medications called central nervous system 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 sounds counterintuitive, but stimulants actually calm things down for many people with ADHD. Dextroamphetamine boosts dopamine and norepinephrine — two brain chemicals involved...
  • What exactly does dextroamphetamine do, and why does a stimulant help with ADHD?
  • The most common ones are decreased appetite, trouble sleeping, and headache — and decreased appetite is very common, especially early on. Taking doses too late in the day tends to...
  • What are the most common side effects I should expect?
📖 Read our full Dextroamphetamine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Orange / Pink
ShapeRound
ImprintN28
Size1 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

6 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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.378 $37.82 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.5935 $59.35 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.8511 $85.11 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.588 $0.239
▲ Up 31% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextroamphetamine Sulfate 10 mg 00406-8959-01 SpecGx 100 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mg 00555-0953-02 Teva 100 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mg 10702-0066-01 KVK-Tech, 100 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mgthis 11534-0189-01 SUNRISE 100 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mg 13107-0036-01 Aurolife 100 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mg 52536-0510-03 Wilshire 30 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mg 75826-0123-10 Winder 100 tablets $0.378 AA Availability likely
Dextroamphetamine Sulfate 10 mg 43386-0871-01 Lupin 100 tablets $0.534 AA FDA listed +41%
Zenzedi 10 mg 24338-0853-03 Azurity 30 tablets AA FDA listed
Dextroamphetamine Sulfate 10 mg 27808-0090-01 Cranbury 100 tablets FDA listed
Dextroamphetamine Sulfate 10 mg 63629-2374-01 Bryant 100 tablets AA FDA listed
Dextroamphetamine Sulfate 10 mg 72162-1234-01 Bryant 100 tablets AA FDA listed
Dextroamphetamine Sulfate 10 mg 72162-2350-03 Bryant 30 tablets AA 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.

Availability & generic status

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ 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 11534-0189-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11.2K
Units reimbursed last 4 qtrs
767.5K
Gross reimbursed last 4 qtrs
$455.5K
Avg / prescription
$40.53
Avg / unit
$0.5935
Latest quarter Q1 2026
2.6KRx
Medicaid pays / ea
$0.5935
gross reimbursed
vs
NADAC / ea
$0.3782
acquisition cost
=
Spread
+$0.2153
+57% 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
42% FFS 58% MCO
Fee-for-service · 4,684 Rx Managed care · 6,555 Rx
State Medicaid map
Alaska: 2,162 units · 295 per 100k residents AK Maine: 7,828 units · 561 per 100k residents ME Washington: 53,295 units · 682 per 100k residents WA Idaho: 10,380 units · 529 per 100k residents ID Montana: 8,612 units · 761 per 100k residents MT North Dakota: 4,495 units · 574 per 100k residents ND Minnesota: 39,084 units · 681 per 100k residents MN Wisconsin: 14,958 units · 253 per 100k residents WI Michigan: 6,929 units · 69.0 per 100k residents MI New York: 66,946 units · 342 per 100k residents NY Vermont: 4,958 units · 766 per 100k residents VT New Hampshire: 4,710 units · 336 per 100k residents NH Oregon: 139,302 units · 3,291 per 100k residents OR Nevada: 720 units · 22.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 8,159 units · 254 per 100k residents IA Illinois: no data reported IL Indiana: 9,940 units · 145 per 100k residents IN Ohio: 8,926 units · 75.7 per 100k residents OH Pennsylvania: 18,123 units · 140 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 6,140 units · 87.7 per 100k residents MA California: 117,002 units · 300 per 100k residents CA Utah: 9,189 units · 269 per 100k residents UT Colorado: 13,714 units · 233 per 100k residents CO Nebraska: no data reported NE Missouri: 17,511 units · 283 per 100k residents MO Kentucky: 11,380 units · 251 per 100k residents KY West Virginia: 8,160 units · 461 per 100k residents WV Virginia: 19,748 units · 227 per 100k residents VA Maryland: 14,473 units · 234 per 100k residents MD Connecticut: 1,108 units · 30.6 per 100k residents CT Rhode Island: 10,806 units · 987 per 100k residents RI Arizona: 10,075 units · 136 per 100k residents AZ New Mexico: 11,174 units · 529 per 100k residents NM Kansas: 3,667 units · 125 per 100k residents KS Arkansas: no data reported AR Tennessee: 690 units · 9.7 per 100k residents TN North Carolina: 20,322 units · 188 per 100k residents NC South Carolina: 4,380 units · 81.5 per 100k residents SC Delaware: 1,768 units · 171 per 100k residents DE Oklahoma: no data reported OK Louisiana: 9,090 units · 199 per 100k residents LA Mississippi: 2,558 units · 87.0 per 100k residents MS Alabama: 17,325 units · 339 per 100k residents AL Georgia: 7,199 units · 65.3 per 100k residents GA D.C.: no data reported DC Hawaii: 9,924 units · 692 per 100k residents HI Texas: 23,652 units · 77.5 per 100k residents TX Florida: 6,869 units · 30.4 per 100k residents FL
Units reimbursed · per 100k residents
9.73,291
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 Oregon 3,291 /100k
2 Rhode Island 987 /100k
3 Vermont 766 /100k
4 Montana 761 /100k
5 Hawaii 692 /100k
6 Washington 682 /100k
7 Minnesota 681 /100k
8 North Dakota 574 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page11534-0189-01 11,239 Rx · $455,476
1000 tablets11534-0189-03 No Medicaid data
Drug total (last 4 qtrs): 11,239 Rx · 767,451 units · $455,476 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Dextroamphetamine Sulfate — the program that covers self-administered drugs. 7 manufacturers.
⚠️ 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 Dextroamphetamine Sulfate. 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
$1.26M
Claims incl. refills
14.4K
Beneficiaries
6.9K
Spend / beneficiary
$182.85
Spend / claim
$87.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Fatigue3,538
Nausea3,178
Headache2,921
Anxiety2,759
Depression2,341
Feeling Abnormal2,210
Pain1,937

Age at onset

Neonate11
Infant9
Child246
Adolescent212
Adult4,172
Elderly408

Reporter sex

45,504 reports

Serious outcomes

Disabling1,082
Life-threatening599
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3,320 1,379
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
11534-0189-01 You're viewing this 100 TABLET in 1 BOTTLE (11534-189-01) $0.3782 / ea $37.82 2018-07-04 Active
11534-0189-03 1000 TABLET in 1 BOTTLE (11534-189-03) 2018-07-04 Active

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

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 11534-0189-01?
NDC 11534-0189-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 11534-0189-01 and NDC 11534-0189-03?
Both are DEXTROAMPHETAMINE SULFATE 10 mg Tablet — the drug itself is identical. NDC 11534-0189-01 is the 100-count package, while NDC 11534-0189-03 is the 1000 tablets package.
What NDC number is used to bill for this package of DEXTROAMPHETAMINE SULFATE 10 mg Tablet?
Bill NDC 11534-0189-01 — the 11-digit billing format is 11534018901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 129 words

WARNING: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine sulfate 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 dextroamphetamine sulfate, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine sulfate, 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 dextroamphetamine sulfate 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 DRUG ABUSE and DEPENDENCE) .

🎯 Indications and Usage 122 words

INDICATIONS AND USAGE Dextroamphetamine Sulfate Tablets USP are indicated for: Narcolepsy . Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia. Narcolepsy Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 years is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained.

If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Attention Deficit Disorder with Hyperactivity Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age , start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained. In pediatric patients 6 years of age and older , start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy. Prior to treating patients with dextroamphetamine sulfate tablets 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]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see WARNINGS].

Contraindications 55 words

CONTRAINDICATIONS Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). Patients with pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received an amphetamine product.

⚠️ Warnings ~3 min read

WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine sulfate has a high potential for abuse and misuse. The use of dextroamphetamine sulfate exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution [see DRUG ABUSE AND DEPENDENCE ].

Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, can result in overdose and death [see OVERDOSAGE], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine sulfate, 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 amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate to anyone else. Throughout dextroamphetamine sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages.

Avoid dextroamphetamine sulfate use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric 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 Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing dextroamphetamine sulfate.

Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients, including dextroamphetamine sulfate. Closely monitor growth (weight and height) in dextroamphetamine sulfate -treated pediatric patients treated with CNS stimulants. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted [see PRECAUTIONS , PEDRIATIC USE].

Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued. Peripheral Vasculopathy, Including Raynaud’s Phenomenon Stimulants, including dextroamphetamine sulfate tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.

Signs a…

🤒 Adverse Reactions 85 words

ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics and Tourette’s syndrome.

Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic Urticaria.

Endocrine Impotence, changes in libido, frequent or prolonged erections. Musculoskeletal Rhabdomyolysis

🆘 Overdosage 150 words

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.

Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of an amphetamine product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI).

Overdose Management Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology 193 words

CLINICAL PHARMACOLOGY Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Pharmacokinetics The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine plasma concentrations (C max ) of 36.6 ng/mL were achieved at approximately 3 hours.

Following administration of one 15 mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average C max was 23.5 ng/mL. The average plasma T 1/2 was similar for both the tablet and sustained-release capsule and was approximately 12 hours.

In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.

📦 How Supplied / Storage and Handling 138 words

HOW SUPPLIED Dextroamphetamine Sulfate Tablets are available as: 5 mg: Peach, round, flat faced, beveled edge tablets, debossed “N” left of bisect “27” on one side and plain on the other side having functional score. Available in bottles of 100 (NDC: 11534-188-01) and 1,000 (NDC: 11534-188-03). 10 mg: Pink, round, flat faced, beveled edge tablets, debossed “N” left of bisect “28” on one side and plain on the other side having functional score.

Available in bottles of 100 (NDC: 11534-189-01) and 1,000 (NDC: 11534-189-03). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured & Distributed By: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 Rev.

07/2026 5359/05

📋 Description 110 words

DESCRIPTION Dextroamphetamine sulfate is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d- alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. The structural formula is as follows: (C 9 H 13 N) 2 .

H 2 SO 4 M.W. 368.49 Inactive Ingredients Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (botanical source: maize). The 5 mg also contains D&C yellow no.

10 aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg also contains FD&C red no.

40 aluminum lake and FD&C yellow no. 6 aluminum lake. image description

💬 Medication Guide ~3 min read

MEDICATION GUIDE DEXTROAMPHETAMINE SULFATE TABLETS USP, CII (dex" troe am fet' a meen sul' fate) What is the most important information I should know about Dextroamphetamine Sulfate Tablets? DEXTROAMPHETAMINE SULFATE TABLETS may cause serious side effects, including: • Abuse misuse, and addiction . DEXTROAMPHETAMINE SULFATE TABLETS has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of DEXTROAMPHETAMINE SULFATE TABLETS, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of DEXTROAMPHETAMINE SULFATE TABLETS or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with DEXTROAMPHETAMINE SULFATE TABLETS and will monitor you or your child during treatment. o DEXTROAMPHETAMINE SULFATE TABLETS may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give DEXTROAMPHETAMINE SULFATE TABLETS to anyone else.

See “ What is DEXTROAMPHETAMINE SULFATE TABLETS? ” for more information. o Keep DEXTROAMPHETAMINE SULFATE TABLETS USP in a safe place and properly dispose of any unused medicine. See “ How should I store DEXTROAMPHETAMINE SULFATE TABLETS? ” for more information. o 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 DEXTROAMPHETAMINE SULFATE TABLETS. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away 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 DEXTROAMPHETAMINE SULFATE TABLETS . • 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 DEXTROAMPHETAMINE SULFATE TABLETS. • Mental (psychiatric) problems, including : o new or worse behavior or thought problems o new or worse bipolar illness o 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 Dextroamphetamine Sulfate Tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What are Dextroamphetamine Sulfate Tablets? Dextroamphetamine Sulfate Tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of: • A sleep disorder called narcolepsy • Attention-Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. • Dextroamphetamine Sulfate Tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Dextroamphetamine Sulfate Tablets are safe and effective in children under 6 years of age. Dextroamphetamine Sulfate Tablets are a federally controlled substance (CII) because it contains dextroamphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Dextroamphetamine Sulfate Tablets in a safe place to protect it from theft.

Never give your Dextroamphetamine Sulfate Tablets to anyone…

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