Quick answers
- What is Dextroamphetamine used for?
- The FDA-approved label (Dexedrine Spansule, Amneal Pharmaceuticals LLC, September 25, 2025) says: “DEXEDRINE is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dextroamphetamine have a boxed warning?
- Yes. The FDA label for Dexedrine Spansule has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dextroamphetamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dextroamphetamine been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started October 31, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dextroamphetamine?
- 17 companies list prescription products of Dextroamphetamine in the FDA NDC Directory, including Bryant Ranch Prepack, Azurity Pharmaceuticals, Inc. and Winder Laboratories LLC.
What Dextroamphetamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DEXEDRINE is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD …
— FDA label: Dexedrine Spansule, Amneal Pharmaceuticals LLC, effective September 25, 2025. Read the full label on DailyMed →
The FDA has 25 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
24 of 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Capsule, extended release · Solution · Patch, extended release |
|---|---|
| Route | Oral · Transdermal |
| Prescription products | 62 in the FDA NDC Directory |
| Brand names | Zenzedi, Xelstrym, Dexedrine Spansule, Procentra |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dextroamphetamine 13.5 mg patch, extended release | Brand: Xelstrym | $16.26 per patch |
| dextroamphetamine 18 mg patch, extended release | Brand: Xelstrym | $16.22 per patch |
| dextroamphetamine 4.5 mg patch, extended release | Brand: Xelstrym | $16.24 per patch |
| dextroamphetamine 9 mg patch, extended release | Brand: Xelstrym | $16.25 per patch |
| dextroamphetamine sulfate 10 mg capsule, extended release | Generic | $1.04 per capsule |
| dextroamphetamine sulfate 10 mg tablet | Generic | $0.3823 per tablet |
| dextroamphetamine sulfate 15 mg capsule, extended release | Generic | $1.33 per capsule |
| dextroamphetamine sulfate 15 mg tablet | Generic | $5.46 per tablet |
| dextroamphetamine sulfate 2.5 mg tablet | Generic | $3.93 per tablet |
| dextroamphetamine sulfate 20 mg tablet | Generic | $5.33 per tablet |
| dextroamphetamine sulfate 30 mg tablet | Generic | $5.48 per tablet |
| dextroamphetamine sulfate 30 mg tablet | Brand: Zenzedi | $10.40 per tablet |
| dextroamphetamine sulfate 5 mg capsule, extended release | Generic | $1.29 per capsule |
| dextroamphetamine sulfate 5 mg tablet | Generic | $0.4106 per tablet |
| dextroamphetamine sulfate 5 mg/5 mL solution | Generic | $1.15 per mL |
| dextroamphetamine sulfate 5 mg/5 mL solution | Brand: Procentra | $1.62 per mL |
| dextroamphetamine sulfate 7.5 mg tablet | Generic | $5.83 per tablet |
NADAC list of November 4, 2026; these prices took effect between April 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- Azurity Pharmaceuticals, Inc.7 products
- Winder Laboratories LLC7 products
- SpecGx LLC5 products
- Wilshire Pharmaceuticals, Inc.5 products
- Noven Therapeutics, LLC4 products
- Cranbury Pharmaceuticals, LLC3 products
- Actavis Pharma, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Amneal Pharmaceuticals LLC3 products
- Sunrise Pharmaceutical, Inc.2 products
- Aurolife Pharma, LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Teva Pharmaceuticals USA, Inc.2 products
- KVK-Tech, Inc.2 products
- Prasco Laboratories1 product
- Independence Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017078 DEXEDRINE SPANSULE | Impax Labs Inc | August 2, 1976 | 40, latest September 23, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
| NDA215401 XELSTRYM | Noven Pharms Inc | March 22, 2022 | 5, latest July 10, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
Generic approvals (13)
- ANDA040361Barr · January 31, 2001
- ANDA040436Specgx LLC · January 29, 2002
- ANDA076353Specgx LLC · May 6, 2003
- ANDA040776Prasco · January 29, 2008
- ANDA090533Azurity · October 25, 2011
- ANDA203901Actavis Elizabeth · November 30, 2012
- ANDA203644Tris Pharma Inc · May 29, 2013
- ANDA202893Aurolife Pharma LLC · July 31, 2013
- ANDA203548Avanthi Inc · November 23, 2015
- ANDA204330Novel Labs Inc · March 16, 2016
- ANDA210059Nuvo Pharm · October 18, 2017
- ANDA212160Winder Labs LLC · June 7, 2021
- ANDA206095Pharmazone · August 18, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 31, 2024 · Class II · Ongoing · D-0055-2025
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN — Noven Pharmaceuticals Inc
-
January 4, 2024 · Class I · Terminated · D-0323-2024
Labeling: Label Mix-up
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03 — Azurity Pharmaceuticals, Inc.
-
July 11, 2016 · Class II · Terminated · D-1448-2016
Failed Dissolution Specifications
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 4596 — Actavis Inc
-
February 10, 2015 · Class II · Terminated · D-0395-2015
Failed Dissolution Specifications
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC — Actavis Elizabeth LLC
-
May 1, 2014 · Class II · Terminated · D-1408-2014
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. — Teva Pharmaceuticals USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dexedrine Spansule, Amneal Pharmaceuticals LLC, effective September 25, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →