Prescription medicine
Amphetamine and dextroamphetamine Brand names: Adderall, Mydayis
Amphetamine and dextroamphetamine (Adderall) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 25 generic labelers, and pharmacies paid $0.233 per dextroamp-amphetamin 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the amphetamine and dextroamphetamine FDA label on DailyMed (effective August 4, 2026, SUNRISE PHARMACEUTICAL, INC.); the NDA 11522 record on Drugs@FDA; every amphetamine and dextroamphetamine label on DailyMed.
Highlights of the record
FDA label of August 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ABUSE, MISUSE, AND ADDICTION DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE.
TABLETS 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 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).
Used for
From the label: indications and usageDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Forms and strengths
- 1.25 mg / 1.25 mg / 1.25 mg / 1.25 mg
- 1.875 mg / 1.875 mg / 1.875 mg / 1.875 mg
- 2.5 mg / 2.5 mg / 2.5 mg / 2.5 mg
- 3.125 mg / 3.125 mg / 3.125 mg / 3.125 mg
- 3.75 mg / 3.75 mg / 3.75 mg / 3.75 mg
- 5 mg / 5 mg / 5 mg / 5 mg
- 6.25 mg / 6.25 mg / 6.25 mg / 6.25 mg
- 7.5 mg / 7.5 mg / 7.5 mg / 7.5 mg
- 12.5 mg / 12.5 mg / 12.5 mg / 12.5 mg
Tablet; extended-release capsule; capsule.
On the market
- Earliest approval on file
- January 19, 1960 Adderall 5, Teva Womens; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 41 first February 11, 2002; 31 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 25 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 24, 2029 Mydayis capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.233 per tablet Dextroamp-amphetamin 10 mg tablet
- Shortage (FDA)
- 28 of 71 presentations limited or unavailable updated October 5, 2026
- Recalls by its makers (FDA)
- 23 since 2013 0 Class I among all firms' recalls; latest June 26, 2026
- FAERS reports
- 41,250 through July 30, 2026
What is amphetamine and dextroamphetamine used for?
From the label: indications and usageDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) 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. […]
Conditions named in the indications of amphetamine and dextroamphetamine's FDA labels, with every medicine labeled for each:
From other amphetamine and dextroamphetamine labelsADHD: … (Mixed Salts of a Single Amphetamine Product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE), SUNRISE PHARMACEUTICAL, INC., effective August 4, 2026 (SPL set ac102599-3a5b-4154-899e-6ff262be7ff7), via openFDA; the full label on DailyMed
Is there a generic for amphetamine and dextroamphetamine (Adderall)?
The FDA approved the first generic amphetamine and dextroamphetamine on February 11, 2002. 41 generic applications are approved; 31 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists amphetamine and dextroamphetamine from 25 labelers under a generic (ANDA) application and from 1 brand labeler. 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 Adderall XR 10 capsules; a patent listed only for Mydayis capsules runs to August 24, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1960 earliest approval on file
- 2002 first generic approved
- 2029 last listed patent
- 2022 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amphetamine and dextroamphetamine (Adderall)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.233 per Dextroamp-amphetamin 10 mg tablet, about the same as a year earlier. 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.
- Dextroamp-amphetamin 10 mg tablet (generic)
- Adderall XR 20 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dextroamp-amphet ER 10 mg capsule | Generic | $0.539 per capsule | $16.18 | +0.5% |
| Dextroamp-amphet ER 15 mg capsule | Generic | $0.557 per capsule | $16.72 | +5% |
| Dextroamp-amphet ER 20 mg capsule | Generic | $0.597 per capsule | $17.90 | -7% |
| Dextroamp-amphet ER 25 mg capsule | Generic | $0.489 per capsule | $14.68 | -12% |
| Dextroamp-amphet ER 30 mg capsule | Generic | $0.466 per capsule | $13.97 | -16% |
| Dextroamp-amphet ER 5 mg capsule | Generic | $0.491 per capsule | $14.74 | -6% |
| Dextroamp-amphetam 12.5 mg tablet | Generic | $0.359 per tablet | $10.78 | -0.8% |
| Dextroamp-amphetam 7.5 mg tablet | Generic | $0.276 per tablet | $8.28 | -10% |
| Dextroamp-amphetamin 10 mg tablet | Generic | $0.233 per tablet | $6.98 | -0.5% |
| Dextroamp-amphetamin 15 mg tablet | Generic | $0.235 per tablet | $7.05 | -10% |
| Dextroamp-amphetamin 20 mg tablet | Generic | $0.290 per tablet | $8.70 | -12% |
| Dextroamp-amphetamin 30 mg tablet | Generic | $0.296 per tablet | $8.87 | -4% |
| Dextroamp-amphetamine 5 mg tablet | Generic | $0.261 per tablet | $7.83 | +0.4% |
| Dextroamph-amphet ER 12.5 mg capsule | Generic | $8.44 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $253.08 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is amphetamine and dextroamphetamine in shortage?
The FDA Drug Shortage Database lists 28 of 71 amphetamine and dextroamphetamine presentations as limited or unavailable (updated October 5, 2026); the first entry was posted on October 12, 2022. 43 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Adderall, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 57844-105-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Adderall, Tablet, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 57844-117-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Adderall, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 57844-110-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Adderall, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 57844-112-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Adderall, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 57844-115-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Adderall, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 57844-120-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Adderall, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 57844-130-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 0185-2098-01) | Sandoz Inc. | Current | September 18, 2026 |
Every amphetamine and dextroamphetamine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has amphetamine and dextroamphetamine been recalled?
The FDA's Enforcement Report lists 23 recalls naming amphetamine and dextroamphetamine since 2013: 0 Class I (the most serious), 11 Class II, 12 Class III; 6 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 26, 2026 | Class II | Lannett Company Inc. | Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. |
| August 28, 2025 | Class III | Granules Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: |
| August 19, 2025 | Class II | Lannett Company Inc. | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine … |
| August 29, 2022 | Class II | Teva Pharmaceuticals USA Inc | Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product. |
| October 9, 2020 | Class III | ANI Pharmaceuticals, Inc. | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. |
| May 22, 2020 | Class II | Teva Pharmaceuticals USA | Some bottles may contain mixed strengths of the product. |
| September 19, 2019 | Class II | Aurobindo Pharma USA Inc. | Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. |
| November 12, 2015 | Class II | Teva Pharmaceuticals USA | Failed Impurities/Degradation Specifications: High 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 amphetamine and dextroamphetamine label say about other medicines?
The amphetamine and dextroamphetamine label names 28 other medicines in its interaction, contraindication or warning sections. 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 | … include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides). |
| Ascorbic acid | drug interactions | Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts). |
| 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 receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning. |
| Desipramine | drug interactions | Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, protriptyline. |
| 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. |
| Fluoxetine | drug interactions | If serotonin syndrome occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and the CYP2D6 inhibitor [see WARNINGS , OVERDOSAGE ]. Examples of CYP2D6 inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. |
| Haloperidol | drug interactions | Haloperidol Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines. |
| Isocarboxazid | drug interactions | … discontinuing MAOI [see CONTRAINDICATIONS and WARNINGS ]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. |
| 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 DRUG INTERACTIONS ]. Patients with pheochromocytoma or a history of pheochromocytoma. |
| Lithium | drug interactions | Lithium Carbonate The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate. |
| Lovastatin | drug interactions | 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. |
| Meperidine | drug interactions | Meperidine Amphetamines potentiate the analgesic effect of meperidine. |
Every other medicine the amphetamine and dextroamphetamine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Methenamine | drug interactions | … acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts). |
| 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 … |
| Omeprazole | drug interactions | An example of a proton pump inhibitor is omeprazole. |
| Paroxetine | drug interactions | … [see WARNINGS , OVERDOSAGE ]. Examples of CYP2D6 inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. |
| Phenelzine | drug interactions | … Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. |
| Phenobarbital | drug interactions | Phenobarbital Amphetamines may delay intestinal absorption of phenobarbital; coadministration of phenobarbital may produce a synergistic anticonvulsant action. |
| Phenytoin | drug interactions | Phenytoin Amphetamines may delay intestinal absorption of phenytoin; coadministration of phenytoin may produce a synergistic anticonvulsant action. |
| Protriptyline | drug interactions | Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, protriptyline. |
| 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. |
| Selegiline | drug interactions | … MAOI [see CONTRAINDICATIONS and WARNINGS ]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. |
| Sodium bicarbonate | drug interactions | … alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides). |
| Tramadol | drug interactions | … inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort. |
| Tranylcypromine | drug interactions | … CONTRAINDICATIONS and WARNINGS ]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. |
Check amphetamine and dextroamphetamine against other medicines
Source: FDA drug label (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE), SUNRISE PHARMACEUTICAL, INC., effective August 4, 2026 (SPL set ac102599-3a5b-4154-899e-6ff262be7ff7), via openFDA; the full label on DailyMed
What do FAERS reports show for amphetamine and dextroamphetamine?
The FDA Adverse Event Reporting System holds 41,250 reports that list amphetamine and dextroamphetamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 504 are coded as a death and 4,904 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 and dextroamphetamine?
8 other medicines are given the same way (oral) and in the same FDA class as amphetamine and dextroamphetamine or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. 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 |
| 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 |
| Viloxazine | ADHD | none listed | $12.74 per capsule 200 mg capsule | No current entry |
Every medicine labeled for the same conditions as amphetamine and dextroamphetamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amphetamine and dextroamphetamine compare with medicines for the same use?
1 side-by-side page set amphetamine and dextroamphetamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amphetamine and dextroamphetamine
- 8 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Amphetamine and dextroamphetamine side effects
- the label's list beside FAERS reports
- Amphetamine and dextroamphetamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other