Prescription medicine
Dextroamphetamine Brand names: Xelstrym, Dexedrine, Zenzedi, Procentra; first approved as Dexedrine Spansule
Dextroamphetamine (Dexedrine) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.373 per dextroamphetamine 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the dextroamphetamine FDA label on DailyMed (effective November 26, 2025, Azurity Pharmaceuticals, Inc.); the NDA 17078 record on Drugs@FDA; every dextroamphetamine label on DailyMed.
Highlights of the record
FDA label of November 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 ).
Used for
From the label: indications and usageZenzedi ® (Dextroamphetamine Sulfate Tablets, USP) is indicated for: Narcolepsy.
Forms and strengths
- 2.5 mg
- 4.5 mg
- 5 mg
- 7.5 mg
- 9 mg
- 10 mg
- 13.5 mg
- 15 mg
- 18 mg
- 20 mg
- 30 mg
- 5 mg/5ml
Tablet; extended-release capsule; solution; extended-release patch.
On the market
- Earliest approval on file
- August 2, 1976 Dexedrine Spansule, Impax Labs Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first May 29, 1975; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 14 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 6, 2042 Xelstrym system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.373 per tablet Dextroamphetamine 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 24 since 2012 1 Class I among all firms' recalls; latest October 31, 2024
- FAERS reports
- 7,605 through July 30, 2026
What is dextroamphetamine used for?
From the label: indications and usageZenzedi ® (Dextroamphetamine Sulfate Tablets, USP) is 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. […]
Conditions named in the indications of dextroamphetamine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (Zenzedi), Azurity Pharmaceuticals, Inc., effective November 26, 2025 (SPL set d6394df5-f2c9-47eb-b57e-f3e9cfd94f84), via openFDA; the full label on DailyMed
What does the patient leaflet for dextroamphetamine 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 Zenzedi?Zenzedi may cause serious side effects, including: Abuse misuse, and addiction. Zenzedi has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Zenzedi, 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 Zenzedi 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 Zenzedi and will monitor you or your child during treatment. Zenzedi may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Zenzedi to anyone else. See “ What is Zenzedi ?” for more information. Keep Zenzedi in a safe place and properly dispose of any unused medicine. See “How should I store Zenzedi?” 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 Zenzedi. 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 Zenzedi. Increased blood pressure and heart rate. […]
From the patient leaflet: What should I avoid while taking Zenzedi?Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Zenzedi affects you.
From the patient leaflet: How should I store Zenzedi?Store Zenzedi at room temperature between 68° to 77°F (20° to 25°C). Store Zenzedi in a safe place, like a locked cabinet. Protect from light. Dispose of remaining, unused, or expired Zenzedi 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 Zenzedi 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 Zenzedi in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep Zenzedi and all medicines out of the reach of children.
Source: FDA drug label (Zenzedi), Azurity Pharmaceuticals, Inc., effective November 26, 2025 (SPL set d6394df5-f2c9-47eb-b57e-f3e9cfd94f84), via openFDA; the full label on DailyMed
Is there a generic for dextroamphetamine (Dexedrine)?
The FDA approved the first generic dextroamphetamine on May 29, 1975. 30 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.
FDA's NDC Directory lists dextroamphetamine from 14 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 no patent for Dexedrine Spansule capsules; a patent listed only for Xelstrym system runs to January 6, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1976 earliest approval on file
- 1975 first generic approved
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dextroamphetamine (Dexedrine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.373 per Dextroamphetamine 10 mg tablet, down 33% from $0.553 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Dextroamphetamine 10 mg tablet (generic)
- Procentra 5 mg/5 mL solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dextroamphetamine 10 mg tablet | Generic | $0.373 per tablet | $11.20 | -33% |
| Dextroamphetamine 15 mg tablet | Generic | $5.45 per tablet | $163.49 | +2% |
| Dextroamphetamine 2.5 mg tablet | Generic | $3.95 per tablet | $118.53 | n/a |
| Dextroamphetamine 20 mg tablet | Generic | $5.41 per tablet | $162.44 | +8% |
| Dextroamphetamine 30 mg tablet | Generic | $5.49 per tablet | $164.70 | +6% |
| Dextroamphetamine 5 mg tablet | Generic | $0.384 per tablet | $11.51 | -26% |
| Dextroamphetamine 5 mg/5 mL | Generic | $1.14 per mL | n/a | -5% |
| Dextroamphetamine 7.5 mg tablet | Generic | $5.83 per tablet | $174.93 | n/a |
| Dextroamphetamine ER 10 mg capsule | Generic | $1.05 per capsule | $31.54 | +18% |
| Dextroamphetamine ER 15 mg capsule | Generic | $1.34 per capsule | $40.13 | +2% |
| Dextroamphetamine ER 5 mg capsule | Generic | $1.10 per capsule | $33.02 | +8% |
| Procentra 5 mg/5 mL solution | Brand | $1.62 per mL | n/a | -0.2% |
| Xelstrym 13.5 mg/9 hr patch | Brand | $16.26 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.4% |
| Xelstrym 18 mg/9 hr patch | Brand | $16.23 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dextroamphetamine been recalled?
The FDA's Enforcement Report lists 24 recalls naming dextroamphetamine since 2012: 1 Class I (the most serious), 23 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 31, 2024 | Class II | Noven Pharmaceuticals Inc | Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). |
| January 4, 2024 | Class I | Azurity Pharmaceuticals, Inc. | Labeling: Label Mix-up |
| August 24, 2016 | Class II | Amerisource Health Services | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule |
| July 11, 2016 | Class II | Actavis Inc | Failed Dissolution Specifications |
| March 14, 2016 | Class II | Impax Laboratories, Inc. | Failed Impurities/Degradation Specifications |
| February 16, 2016 | Class II | Actavis Elizabeth LLC | Failed Impurities/Degradation Specifications: Out of specification for impurities. |
| February 10, 2015 | Class II | Actavis Elizabeth LLC | Failed Dissolution Specifications |
| May 1, 2014 | Class II | Teva Pharmaceuticals USA | Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dextroamphetamine label say about other medicines?
The dextroamphetamine label names 30 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name dextroamphetamine. 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. |
| Amphetamine | contraindications | CONTRAINDICATIONS Known hypersensitivity to amphetamine products. |
| Ascorbic acid | drug interactions | Acidifying Agents Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. |
| Atomoxetine | drug interactions | … adjustment for drugs that are substrates of CYP1A2 (e.g. theophylline, duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. … |
| Buspirone | drug interactions | … reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort. |
| Chlorpromazine | drug interactions | Chlorpromazine Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning. |
| Clobazam | drug interactions | … duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is necessary when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. |
| 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. |
| Duloxetine | drug interactions | … pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g. theophylline, duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. … |
| Ethosuximide | drug interactions | Ethosuximide Amphetamines may delay intestinal absorption of ethosuximide. |
| Fentanyl | drug interactions | … inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort. |
| Guanfacine | drug interactions | … pharmacokinetic perspective, no dose adjustment of XELSTRYM is necessary when XELSTRYM is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. … |
| Haloperidol | drug interactions | Haloperidol Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines. |
| Lansoprazole | drug interactions | … theophylline, duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is necessary when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. |
Every other medicine the dextroamphetamine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Linezolid | contraindications | … (MAOI), 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) … |
| Lithium | drug interactions | … inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort. |
| 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 | … 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) and DRUG INTERACTIONS … |
| Midazolam | drug interactions | … CYP2C19 (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is necessary when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. |
| Omeprazole | drug interactions | … when XELSTRYM is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when XELSTRYM is co-administered [see CLINICAL … |
| Phenobarbital | drug interactions | Phenobarbital Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action. |
| Phenytoin | drug interactions | Phenytoin Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action. |
| Pimozide | drug interactions | … (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is necessary when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. |
| 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 … |
| Simvastatin | drug interactions | … omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is necessary when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. |
| Sodium bicarbonate | drug interactions | Alkalinizing Agent Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. |
| Theophylline | drug interactions | … perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g. theophylline, duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g. … |
| Tramadol | drug interactions | … inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort. |
| Venlafaxine | drug interactions | … XELSTRYM is necessary when XELSTRYM is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when XELSTRYM is … |
Other labels that name dextroamphetamine
Source: FDA drug label (Zenzedi), Azurity Pharmaceuticals, Inc., effective November 26, 2025 (SPL set d6394df5-f2c9-47eb-b57e-f3e9cfd94f84), via openFDA; the full label on DailyMed
What do FAERS reports show for dextroamphetamine?
The FDA Adverse Event Reporting System holds 7,605 reports that list dextroamphetamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 217 are coded as a death and 1,181 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 dextroamphetamine?
9 other medicines are given the same way (oral) and in the same FDA class as dextroamphetamine 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 |
| Amphetamine | ADHD | 13 labelers | $0.449 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 dextroamphetamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dextroamphetamine compare with medicines for the same use?
6 side-by-side pages set dextroamphetamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dextroamphetamine
- 9 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Dextroamphetamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other