Prescription medicine
Amphetamine Brand names: Adzenys, Dyanavel, Evekeo; first approved as Adzenys Xr-Odt
Amphetamine (Dyanavel) is a prescription medicine with an FDA approval on record since 2016. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.449 per amphetamine sulfate 10 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.76 per mL (Dyanavel XR 2.5 mg/mL suspension).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the amphetamine FDA label on DailyMed (effective August 20, 2026, Aurolife Pharma, LLC); the NDA 204326 record on Drugs@FDA; every amphetamine label on DailyMed.
Highlights of the record
FDA label of August 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
WARNING: ABUSE, MISUSE, AND ADDICTION AMPHETAMINE SULFATE TABLET 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 AMPHETAMINE 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 amphetamine sulfate tablet, 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 amphetamine sulfate tablet 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)].
Used for
From the label: indications and usageAmphetamine 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 children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility,
Forms and strengths
- 3.1 mg
- 5 mg
- 6.3 mg
- 9.4 mg
- 10 mg
- 12.5 mg
- 15 mg
- 15.7 mg
- 18.8 mg
- 20 mg
- 2.5 mg/ml
Tablet; orally disintegrating tablet; extended-release tablet; extended-release suspension.
On the market
- Earliest approval on file
- January 27, 2016 Adzenys Xr-Odt, Neos Theraps; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first February 26, 1976; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 13 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 28, 2032 Adzenys Xr-Odt tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.449 per tablet Amphetamine sulfate 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,452 through July 30, 2026
What is amphetamine used for?
From the label: indications and usageAmphetamine 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 children with 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 the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. […]
Conditions named in the indications of amphetamine's FDA labels, with every medicine labeled for each:
From other amphetamine labelsADHD: Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 …
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (Amphetamine Sulfate), Aurolife Pharma, LLC, effective August 20, 2026 (SPL set 20735c2e-6304-425f-a4e4-584f6f90d6a0), via openFDA; the full label on DailyMed
What does the patient leaflet for amphetamine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Amphetamine Sulfate Tablets, USP?Amphetamine Sulfate Tablets may cause serious side effects, including: ·· Abuse, misuse, and addiction. Amphetamine Sulfate Tabletshas a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Amphetamine Sulfate Tablets, other amphetamine containing medicines, and methylphenidate, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Amphetamine 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 withAmphetamine Sulfate Tablets and will monitor you or your child during treatment. o Amphetamine Sulfate Tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give Amphetamine Sulfate Tablets to anyone else. See “What is Amphetamine Sulfate Tablets?” for more information. o Keep Amphetamine Sulfate Tablets in a safe place and properly dispose of unused medicine. See “How should I store Amphetamine 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 Amphetamine Sulfate Tablets. Tell your healthcare provider if you or your child have any heart problems, heart disease or heart defects. […]
From the patient leaflet: What should I avoid while taking Amphetamine Sulfate Tablets?Do not drive, operate machinery, or do other dangerous activities until you know how Amphetamine Sulfate Tablets affects you.
From the patient leaflet: How should I store Amphetamine Sulfate Tablets?· Store Amphetamine Sulfate Tablets at room temperature between 68°F to 77°F (20°C to 25°C). · Store Amphetamine Sulfate Tablets in a safe place, like a locked cabinet. · Dispose of remaining, unused, or expired Amphetamine Sulfate Tablets by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix Amphetamine Sulfate Tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Amphetamine Sulfate Tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep Amphetamine Sulfate Tablets and all medicines out of the reach of children.
Source: FDA drug label (Amphetamine Sulfate), Aurolife Pharma, LLC, effective August 20, 2026 (SPL set 20735c2e-6304-425f-a4e4-584f6f90d6a0), via openFDA; the full label on DailyMed
Is there a generic for amphetamine (Dyanavel)?
The FDA approved the first generic amphetamine on February 26, 1976. 19 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists amphetamine from 13 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 5 patents for Adzenys Xr-Odt tablets, the last expiring on June 28, 2032; a patent listed only for Evekeo ODT tablets runs to March 10, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 1976 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amphetamine (Dyanavel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.449 per Amphetamine sulfate 10 mg tablet, up 14% from $0.393 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Amphetamine sulfate 10 mg tablet (generic)
- Dyanavel XR 2.5 mg/mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amphetamine ER 12.5 mg ODT | Generic | $15.96 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Amphetamine ER 15.7 mg ODT | Generic | $15.93 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Amphetamine ER 18.8 mg ODT | Generic | $15.61 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Amphetamine ER 3.1 mg ODT | Generic | $15.84 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Amphetamine ER 6.3 mg ODT | Generic | $16.07 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Amphetamine ER 9.4 mg ODT | Generic | $16.22 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Amphetamine sulfate 10 mg tablet | Generic | $0.449 per tablet | $13.47 | +14% |
| Amphetamine sulfate 5 mg tablet | Generic | $0.457 per tablet | $13.72 | -20% |
| Adzenys XR-ODT 12.5 mg tablet | Brand | $19.21 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $576.16 | -0.3% |
| Adzenys XR-ODT 15.7 mg tablet | Brand | $19.16 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $574.91 | -0.6% |
| Adzenys XR-ODT 18.8 mg tablet | Brand | $19.21 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $576.33 | -0.4% |
| Adzenys XR-ODT 3.1 mg tablet | Brand | $19.20 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $576.14 | no change |
| Adzenys XR-ODT 6.3 mg tablet | Brand | $19.21 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $576.27 | -0.3% |
| Adzenys XR-ODT 9.4 mg tablet | Brand | $19.18 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $575.51 | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the amphetamine label say about other medicines?
The amphetamine label names 22 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name amphetamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. |
| Ascorbic acid | drug interactions | Acidifying agents Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. |
| Buspirone | warnings | … reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort (see DRUG INTERACTIONS). |
| Chlorpromazine | drug interactions | Chlorpromazine Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine, and can be used to treat amphetamine poisoning. |
| Desipramine | drug interactions | Antidepressants tricyclic Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d- amphetamine in the brain; cardiovascular effects can be potentiated. |
| Ethosuximide | drug interactions | Ethosuximide Amphetamines may delay intestinal absorption of ethosuximide. |
| Fentanyl | warnings | … inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort (see DRUG INTERACTIONS). |
| Fluoxetine | drug interactions | If serotonin syndrome occurs, discontinue Amphetamine Sulfate Tablet and the CYP2D6 inhibitor (see WARNING, OVERDOSAGE). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. |
| Haloperidol | drug interactions | Haloperidol Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant affects of amphetamines. |
| Linezolid | contraindications | 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 Precautions (5.7), Drug Interactions (7.1) ]. |
| Lithium | drug interactions | Lithium carbonate The antiobesity and stimulatory effects of amphetamines may be inhibited by lithium carbonate. |
| Meperidine | drug interactions | Meperidine Amphetamines potentiate the analgesic effect of meperidine. |
| Methenamine | drug interactions | Methenamine therapy Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy. |
| Methylene blue | contraindications | 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 Precautions (5.7), Drug Interactions (7.1) ]. |
Every other medicine the amphetamine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Paroxetine | drug interactions | … inhibitor (see WARNING, OVERDOSAGE). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. |
| Phenobarbital | drug interactions | Phenobarbital Amphetamines may delay intestinal absorption of Phenobarbital. |
| Phenytoin | drug interactions | Phenytoin Amphetamines may delay intestinal absorption of phenytoin; co- administration of phenytoin may produce a synergistic anticonvulsant action. |
| Protriptyline | drug interactions | Antidepressants tricyclic Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking … |
| Quinidine | drug interactions | … Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. |
| Ritonavir | drug interactions | … include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. |
| Sodium bicarbonate | drug interactions | Alkalinizing agents Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. |
| Tramadol | warnings | … inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort (see DRUG INTERACTIONS). |
Other labels that name amphetamine
Source: FDA drug label (Amphetamine Sulfate), Aurolife Pharma, LLC, effective August 20, 2026 (SPL set 20735c2e-6304-425f-a4e4-584f6f90d6a0), via openFDA; the full label on DailyMed
What do FAERS reports show for amphetamine?
The FDA Adverse Event Reporting System holds 8,452 reports that list amphetamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,903 are coded as a death and 1,842 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amphetamine?
9 other medicines are given the same way (oral) and in the same FDA class as amphetamine or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Lisdexamfetamine | ADHD | 19 labelers | $2.44 per capsule 20 mg capsule | In shortage |
| Dexmethylphenidate | ADHD | 13 labelers | $1.45 per capsule 10 mg capsule | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
| Dexmethylphenidate and serdexmethylphenidate | ADHD | none listed | $14.40 per capsule 26.1 mg-5.2 mg capsule | No current entry |
| Methamphetamine | ADHD | 3 labelers | $5.10 per tablet 5 mg tablet | No current entry |
| Atomoxetine | ADHD | 20 labelers | $0.442 per capsule 40 mg capsule | No current entry |
| Guanfacine | ADHD | 37 labelers | $0.147 per tablet 1 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as amphetamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amphetamine compare with medicines for the same use?
5 side-by-side pages set amphetamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amphetamine
- 9 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Amphetamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other