Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg Tablet, 100-count — NDC 47781-0178-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg Tablet, 100-count — NDC 47781-178-01 (Billing 47781-0178-01)

by Alvogen Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg Tablet from Alvogen Inc., marketed since Jul 2017 and currently FDA-listed; retail pharmacies pay about $0.2351 per tablet (NADAC). It is this product's only package size.

NDC 47781-0178-01
🏷️ FDA NDC (as labeled) 47781-178-01 billing pads the product segment with a zero
Rx only Generic On market CII ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Active FDA shortage. Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet is currently reported in shortage by the FDA. Available Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47781-178-01
Product NDC 47781-178
11-digit billing NDC 47781017801
NCPDP billing unit EA — each (per item)
Application # ANDA207388
SPL Set ID c907301d-e24d-9609-5529-fed14f94549f
Established class (EPC) Central Nervous System Stimulant; Central Nervo
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-28
Route ORAL
Dosage form TABLET
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 047133
GCN 29009
HICL code 013449
Ingredient (HICL) Dextroamphetamine/Amphetamine
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 DEXTROAMP-AMPHETAMIN 15 MG TAB
FDB brand name Dextroamphetamine-Amphetamine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047133
  • GCN: 29009
  • HICL (First Databank): 013449
  • AHFS class code: 28:20.04.00
Why two NDCs? The FDA registers this code as 47781-178-01 — 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 → 47781-0178-01. 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.

Clinical

Label name DEXTROAMP-AMPHETAMIN 15 MG TAB Ingredient Dextroamphetamine/Amphetamine
📖 What it is MedlinePlus · NLM

The combination of dextroamphetamine and amphetamine (Adderall®, Adderall® XR, Mydayis®) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Adderall® is used to treat ADHD in adults and children 3 years of age and older. Adderall® XR is used to treat ADHD in adults and children 6 years of age and older. Mydayis® is used to treat ADHD in adults and children 13 years of age and older. Dextroamphetamine and amphetamine (Add...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats ADHD. Some tablet products, including Adderall tablets, are also used for narcolepsy. Which product you have determines the approved ages and uses.
  • Extended-release capsules are usually taken once a day in the morning, because they can last up to 16 hours and may disturb sleep. Take it the same way each day, with or without fo...
  • Loss of appetite, trouble sleeping, stomach pain, nervousness and weight loss are common. Adults may also get dry mouth and headache. Call your doctor if these are bothersome or se...
  • It has a high potential for abuse and misuse, which can lead to addiction and overdose. Take only as prescribed, never share it, store it locked up, and dispose of leftovers safely...
📖 Read our full Amphetamine / Amphetamine Aspartate / Dextroamphetamine / Dextroamphetamine Saccharate 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.

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 $0.235 $23.51 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.4232 $42.32 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.314 $0.232
▼ Down 12% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
47781-0178-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2017-07-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 00406-8885-01 SpecGx 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 00527-0764-37 Lannett 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 00555-0777-02 Teva 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 11534-0194-01 SUNRISE 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 13107-0072-01 Aurolife 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 16714-0952-01 NorthStar 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 31722-0159-01 Camber 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 42806-0343-01 Epic 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 42858-0725-01 Rhodes 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mgthis 47781-0178-01 Alvogen 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 64850-0504-01 Elite 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 68462-0651-01 GLENMARK 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 70010-0115-01 Granules 100 tablets $0.235 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 72516-0013-01 Oryza 100 tablets $0.235 AB Availability likely —
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 16714-0806-01 Northstar 100 tablets $0.250 AB FDA listed +6%
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 57664-0645-08 Sun 100 tablets $0.314 AB FDA listed +33%
Adderall 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 57844-0115-01 Teva 100 tablets $12.312 AB Availability likely +5136%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 55466-0131-12 Neolpharma, 100 tablets — AB Discontinued —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 63629-2378-01 Bryant 100 tablets — AB Discontinued —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg 72162-2052-01 Bryant 100 tablets — AB Discontinued —
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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 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.

What it looks like

Color White / Blue / Orange
ShapeRound
Imprint80;A
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 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 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 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.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAlvogen Inc.
Application holderALVOGEN INC
FDA applicationANDA207388 (ANDA)
Labeler code47781
First marketedJul 2017
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio51 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.

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 162 words ▾

WARNING: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 DRUG ABUSE AND DEPENDENCE ).

🎯 Indications and Usage 202 words ▾

INDICATIONS AND USAGE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home.

The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive.

The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder Not recommended for children under 3 years of age.

In children 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 children 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine 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 before initiating Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (see WARNINGS ).

Narcolepsy Usual dose 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 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until 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.

⛔ Contraindications 81 words ▾

CONTRAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products (see ADVERSE REACTIONS ). Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis (see WARNINGS and DRUG INTERACTIONS ).

⚠️ Warnings ~2 min read ▾

WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets have a high potential for abuse and misuse. The use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE AND DEPENDENCE: Abuse ).

Misuse and abuse of CNS stimulants, including Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets in a safe place, preferably locked, and instruct patients to not give Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets to anyone else. Throughout Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 were treated with CNS stimulant treatment at the recommended ADHD dosages. Avoid Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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).

Some patients may have larger increases. Monitor all Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets-treated patients for potential tachycardia and hypertension. Psychiatric Adverse Reactions Exacerbation of Preexisting 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Long-Term Suppressi… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 110 words ▾

ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania.

Eye Disorders Vision blurred, mydriasis. 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, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido, frequent or prolonged erections.

Skin Alopecia. Musculoskeletal Rhabdomyolysis.

🔄 Drug Interactions ~2 min read ▾

Drug Interactions MAO Inhibitors Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets concomitantly or within 14 days after discontinuing MAOI (see CONTRAINDICATIONS and WARNINGS ).

Serotonergic Drugs The concomitant use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and the concomitant serotonergic drug(s) (see WARNINGS and PRECAUTIONS ).

CYP2D6 Inhibitors The concomitant use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and CYP2D6 inhibitors may increase the exposure of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets initiation and after a dosage increase.

If serotonin syndrome occurs, discontinue Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and the CYP2D6 inhibitor (see WARNINGS , OVERDOSAGE ). Acidifying Agents Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response.

Examples of acidifying agents include gastrointestinal acidifying agents and urinary acidifying agents. Adrenergic Blockers Adrenergic blockers are inhibited by amphetamines. Alkalinizing Agents Increase blood levels and potentiate the action of amphetamine.

Co-administration of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents and urinary alkalinizing agents. Tricyclic Antidepressants May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Monitor frequently and adjust or use alternative therapy based on clinical response. Antihistamines Amphetamines may counteract the sedative effect of antihistamines. Antihypertensives Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning. Ethosuximide Amphetamines may delay intestinal absorption of ethosuximide. Haloperidol Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.

Lithium Carbonate The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate. Meperidine Amphetamines potentiate the analgesic effect of meperidine. Methenamine Therapy Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Norepinephrine Amphetamines enhance the adrenergic effect of norepinephrine. Phe… [Excerpted — this section continues on DailyMed.]

🔄 Drug / Laboratory Test Interactions 27 words ▾

Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m 2 body surface area basis.

Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m 2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations.

Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy.

Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

🧒 Pediatric Use 37 words ▾

Pediatric Use Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under INDICATIONS AND USAGE .

🧓 Geriatric Use 20 words ▾

Geriatric Use Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets have not been studied in the geriatric population.

🆘 Overdosage 96 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.

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

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 mg or 30 mg of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine.

The mean elimination half-life (t 1/2 ) for d-amphetamine was shorter than the t 1/2 of the l-isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (C max , AUC 0-inf ) of d- and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.

The effect of food on the bioavailability of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has not been studied. Metabolism and Excretion Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine.

Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.

Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.

With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose is recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion.

Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that affect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine’s metabolism that might occur due to drug interactions or genetic polymorphism… [Excerpted — this section continues on DailyMed.]

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

HOW SUPPLIED Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg: Round, flat-faced, beveled-edge, white tablet. “74” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “4”. They are supplied as follows: 100 Tablets NDC 47781-174-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 7.5 mg: Round, flat-faced, beveled-edge, blue tablet. “75” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side.

The full bisect splits the “7” and “5”. They are supplied as follows: 100 Tablets NDC 47781-175-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 10 mg: Round, flat-faced, beveled-edge, blue tablet. “76” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “6”.

They are supplied as follows: 100 Tablets NDC 47781-176-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg: Round, flat-faced, beveled-edge, orange tablet. “77” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “7”. They are supplied as follows: 100 Tablets NDC 47781-177-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 15 mg: Round, flat-faced, beveled-edge, orange tablet. “78” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side.

The full bisect splits the “7” and “8”. They are supplied as follows: 100 Tablets NDC 47781-178-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 20 mg: Round, flat-faced, beveled-edge, orange tablet. “79” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “9”.

They are supplied as follows: 100 Tablets NDC 47781-179-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 30 mg: Round, flat-faced, beveled-edge, orange tablet. "80" is debossed on one side with a full and partial bisect, and "A" is debossed on the opposite side. The full bisect splits the "8" and "0". They are supplied as follows: 100 Tablets NDC 47781-180-01 Dispense in a tight, light-resistant container.

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

📋 Description ~2 min read ▾

DESCRIPTION A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. EACH TABLET CONTAINS 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate Equivalent 1.25 mg a 1.875 mg b 2.5 mg c 3.125 mg d 3.75 mg e 5 mg f 7.5 mg g Dextroamphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied b 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied c 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied d 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied f 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied g 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.

Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.

💬 Medication Guide ~2 min read ▾

MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII (dex’ troe am fet’ a meen sak’ a rate, am fet’ a meen a spar’ tate, dex’ troe am fet’ a meen sul’ fate, am fet’ a meen sul’ fate) What is the most important information I should know about Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets? Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets may cause serious side effects, including: Abuse, misuse, and addiction.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and will monitor you or your child during treatment. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets to anyone else.

See " What are Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ? " for more information. Keep Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets in a safe place and properly dispose of any unused medicine. See “ How should I store Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms. Tell your healthcare provider about any mental problems you or your ch… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide). Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly. Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, which can lead to overdose and death, and proper disposal of any unused drug (see WARNINGS , DRUG ABUSE AND DEPENDENCE, OVERDOSAGE ).

Advise patients to store Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets in a safe place, preferably locked, and instruct patients to not give Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 ). Increased Blood Pressure and Heart Rate Advise patients that Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets can elevate blood pressure and heart rate (see WARNINGS ). Psychiatric Adverse Reactions Advise patients that Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania (see WARNINGS ).

Long-Term Suppression of Growth in Pediatric Patients Advise patients that Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets may cause slowing of growth including weight loss (see WARNINGS ). Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] Instruct patients beginning treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid (see CONTRAINDICATIONS , WARNINGS, and DRUG INTERACTIONS ).

Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Motor and Verbal Tics, and Worsening o… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 20 words ▾

Usage in Nursing Mothers Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

🔒 Drug Abuse and Dependence ~2 min read ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets contain amphetamine, a Schedule II controlled substance. Abuse Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 ). Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets can be diverted for non-medical use into illicit channels or distribution.

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

Misuse and abuse of amphetamines 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 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.

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

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

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

Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m 2 body surface area basis. Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (immediate release)(d- to l- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro . d, l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (immediate release)(d- to l- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose of 30 mg/day on a mg/m 2 body surface area basis).

📄 Package Label / Principal Display Panel ~1 min read ▾

NDC 47781- 174 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 5 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

NDC 47781- 175 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 7.5 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

NDC 47781- 176 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 10 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

NDC 47781- 177 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 12.5 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

NDC 47781- 178 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 15 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

NDC 47781- 179 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 20 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

NDC 47781- 180 -01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets CII (Mixed Salts of a Single Entity Amphetamine Product) 30 mg PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx only 100 Tablets

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – 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
46.3K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$903K
Avg / prescription
$19.52
Avg / unit
$0.4232
Latest quarter Q1 2026
13.6KRx
Medicaid pays / ea
$0.4232
gross reimbursed
vs
NADAC / ea
$0.2351
acquisition cost
=
Spread
+$0.1881
+80% 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 ⓘ
40% FFS 60% MCO
Fee-for-service · 18,330 Rx Managed care · 27,923 Rx
State Medicaid map
Alaska: 5,193 units · 708 per 100k residents AK Maine: 20,382 units · 1,461 per 100k residents ME Washington: 65,968 units · 844 per 100k residents WA Idaho: 13,073 units · 666 per 100k residents ID Montana: 20,367 units · 1,799 per 100k residents MT North Dakota: 2,860 units · 365 per 100k residents ND Minnesota: 56,007 units · 976 per 100k residents MN Wisconsin: 8,736 units · 148 per 100k residents WI Michigan: 67,192 units · 669 per 100k residents MI New York: 119,905 units · 613 per 100k residents NY Vermont: 3,501 units · 541 per 100k residents VT New Hampshire: 12,284 units · 876 per 100k residents NH Oregon: 63,877 units · 1,509 per 100k residents OR Nevada: 75,572 units · 2,366 per 100k residents NV Wyoming: 1,486 units · 254 per 100k residents WY South Dakota: 7,331 units · 798 per 100k residents SD Iowa: 35,272 units · 1,100 per 100k residents IA Illinois: 29,151 units · 232 per 100k residents IL Indiana: 38,191 units · 557 per 100k residents IN Ohio: 128,915 units · 1,094 per 100k residents OH Pennsylvania: 115,289 units · 890 per 100k residents PA New Jersey: 49,022 units · 528 per 100k residents NJ Massachusetts: 22,078 units · 315 per 100k residents MA California: 312,579 units · 802 per 100k residents CA Utah: 32,601 units · 954 per 100k residents UT Colorado: 31,040 units · 528 per 100k residents CO Nebraska: 13,244 units · 670 per 100k residents NE Missouri: 20,342 units · 328 per 100k residents MO Kentucky: 36,822 units · 814 per 100k residents KY West Virginia: 16,326 units · 922 per 100k residents WV Virginia: 24,274 units · 278 per 100k residents VA Maryland: 85,031 units · 1,376 per 100k residents MD Connecticut: 18,252 units · 505 per 100k residents CT Rhode Island: 8,519 units · 778 per 100k residents RI Arizona: 75,811 units · 1,020 per 100k residents AZ New Mexico: 6,942 units · 328 per 100k residents NM Kansas: 8,253 units · 281 per 100k residents KS Arkansas: 4,161 units · 136 per 100k residents AR Tennessee: 17,991 units · 252 per 100k residents TN North Carolina: 46,936 units · 433 per 100k residents NC South Carolina: 14,141 units · 263 per 100k residents SC Delaware: 3,744 units · 363 per 100k residents DE Oklahoma: 25,331 units · 625 per 100k residents OK Louisiana: 76,095 units · 1,664 per 100k residents LA Mississippi: 10,725 units · 365 per 100k residents MS Alabama: 16,318 units · 319 per 100k residents AL Georgia: 43,035 units · 390 per 100k residents GA D.C.: 3,716 units · 547 per 100k residents DC Hawaii: 13,653 units · 951 per 100k residents HI Texas: 47,458 units · 156 per 100k residents TX Florida: 137,297 units · 607 per 100k residents FL
Units reimbursed · per 100k residents
1362,366
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 Nevada 2,366 /100k
2 Montana 1,799 /100k
3 Louisiana 1,664 /100k
4 Oregon 1,509 /100k
5 Maine 1,461 /100k
6 Maryland 1,376 /100k
7 Iowa 1,100 /100k
8 Ohio 1,094 /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.
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.